Siemens Healthcare Diagnostics, Inc.
665 recalls on record · Latest: Aug 12, 2026
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Agency notice ledger
Federal filing book Siemens Healthcare Diagnost… HEAVY-BOOK · SINGLE-AGENCY
#6 of 14,151 · 665 notices · 0.637% archive
- BOOK 665 notices
- RANK #6 of 14,151
- SHARE 0.637% archive
- AGENCY FDA Devices (665)
- CAT medical devices
- CATS 1 category
- LATEST Aug 12, 2026
- PHOTO Icu Medical, Inc.
Nearest notice-volume peer: Icu Medical, Inc. (8 notice gap)
Siemens Healthcare Diagnostics, Inc. sits #6 of 14,151 (6th among 14,151 firms) with 665 federal notices — about 0.637% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Siemens Healthcare Diagnost… compares to 14,151 recalling firms
Siemens Healthcare Diagnostics, Inc. ranks 6th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Siemens Healthcare Diagnost… vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
665 6th of 14151 higher than 14,145 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14
Siemens Healthcare Diagnost… in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
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682 notices
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Siemens Healthcare Diagnostics, Inc.
665 notices
- Icu Medical,…
Icu Medical, Inc.
657 notices
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657 notices
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632 notices
What this shows Siemens Healthcare Diagnostics, Inc. carries 665 distinct federal notices, ranked #6 of 14,151 (heavy-book).
FDA Devices Moderate Mar 18, 2015
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
FDA Devices Moderate Mar 18, 2015
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10328655 Legacy Part number: 478527
FDA Devices Moderate Mar 18, 2015
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
FDA Devices Moderate Mar 18, 2015
Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601
FDA Devices Moderate Mar 18, 2015
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOH
FDA Devices Moderate Mar 11, 2015
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
FDA Devices Moderate Mar 11, 2015
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
FDA Devices Moderate Mar 11, 2015
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
FDA Devices Moderate Jan 21, 2015
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
FDA Devices Moderate Jan 14, 2015
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
FDA Devices Moderate Dec 31, 2014
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
FDA Devices Moderate Dec 31, 2014
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
FDA Devices Moderate Dec 31, 2014
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
FDA Devices Moderate Dec 24, 2014
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Devices Moderate Dec 3, 2014
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
FDA Devices Low Nov 26, 2014
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
FDA Devices Low Nov 26, 2014
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
FDA Devices Critical Nov 19, 2014
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Devices Critical Nov 19, 2014
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Devices Low Nov 19, 2014
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
FDA Devices Moderate Nov 12, 2014
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
FDA Devices Moderate Nov 5, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
FDA Devices Moderate Nov 5, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
FDA Devices Moderate Nov 5, 2014
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
FDA Devices Moderate Nov 5, 2014
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
FDA Devices Moderate Nov 5, 2014
Dimension Vista¿ HbA1c
FDA Devices Moderate Oct 29, 2014
Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
FDA Devices Moderate Oct 29, 2014
ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
FDA Devices Moderate Oct 22, 2014
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
FDA Devices Moderate Oct 22, 2014
External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
FDA Devices Moderate Oct 22, 2014
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
FDA Devices Moderate Oct 15, 2014
Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
FDA Devices Moderate Oct 8, 2014
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System.
FDA Devices Moderate Sep 24, 2014
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
FDA Devices Moderate Sep 10, 2014
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
FDA Devices Moderate Sep 3, 2014
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
FDA Devices Moderate Aug 27, 2014
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
FDA Devices Moderate Aug 13, 2014
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
FDA Devices Moderate Aug 13, 2014
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
FDA Devices Low Aug 6, 2014
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
FDA Devices Moderate Jul 30, 2014
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813
FDA Devices Moderate Jul 23, 2014
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
FDA Devices Low Jul 23, 2014
Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
FDA Devices Moderate Jul 9, 2014
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
FDA Devices Moderate Jul 9, 2014
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
FDA Devices Moderate Jul 9, 2014
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
FDA Devices Moderate Jul 9, 2014
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
FDA Devices Moderate Jul 2, 2014
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
FDA Devices Moderate Jul 2, 2014
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments
FDA Devices Moderate Jul 2, 2014
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Siemens Healthcare Diagnost… sits in the heavy federal notice book
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (665 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Siemens Healthcare Diagnost…? ▼
PlainRecalls indexes 665 distinct federal recall events naming Siemens Healthcare Diagnostics, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Siemens Healthcare Diagnost… sit among other recalling firms? ▼
Siemens Healthcare Diagnostics, Inc. ranks #6 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Siemens Healthcare Diagnost…'s notices? ▼
FDA Devices accounts for 665 of this firm's 665 indexed notices.
What product category dominates Siemens Healthcare Diagnost…'s filing book? ▼
Filings for Siemens Healthcare Diagnostics, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Siemens Healthcare Diagnostics, Inc.: 665 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Siemens Healthcare Diagnostics, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026