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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Siemens Healthcare Diagnostics, Inc.
665 notices
- Icu Medical,…
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657 notices
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What this shows Siemens Healthcare Diagnostics, Inc. carries 665 distinct federal notices, ranked #6 of 14,151 (heavy-book).
FDA Devices Moderate Dec 21, 2022
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
FDA Devices Moderate Dec 14, 2022
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
FDA Devices Moderate Oct 26, 2022
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
FDA Devices Moderate Oct 26, 2022
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
FDA Devices Moderate Oct 26, 2022
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
FDA Devices Moderate Oct 26, 2022
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
FDA Devices Moderate Oct 26, 2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
FDA Devices Moderate Oct 5, 2022
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
FDA Devices Moderate Oct 5, 2022
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
FDA Devices Moderate Sep 7, 2022
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
FDA Devices Moderate Aug 10, 2022
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
FDA Devices Moderate Jul 20, 2022
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
FDA Devices Moderate Jul 13, 2022
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
FDA Devices Moderate Jul 13, 2022
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
FDA Devices Moderate Jun 15, 2022
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
FDA Devices Moderate Jun 15, 2022
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
FDA Devices Moderate May 4, 2022
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Devices Moderate Apr 20, 2022
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
FDA Devices Moderate Apr 20, 2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
FDA Devices Moderate Apr 20, 2022
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
FDA Devices Moderate Apr 20, 2022
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
FDA Devices Moderate Apr 6, 2022
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high pl
FDA Devices Moderate Jan 12, 2022
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
FDA Devices Moderate Jan 5, 2022
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
FDA Devices Moderate Dec 8, 2021
Dimension Vista 500- 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 fluid SMN: 10284473 (US) and 10488224 (OUS)
FDA Devices Moderate Dec 8, 2021
Dimension Vista 1500 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 fluid SMN: 10444801(US) and 10444802 (OUS)
FDA Devices Moderate Nov 10, 2021
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
FDA Devices Moderate Nov 10, 2021
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
FDA Devices Moderate Nov 10, 2021
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
FDA Devices Moderate Nov 3, 2021
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
FDA Devices Moderate Nov 3, 2021
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
FDA Devices Moderate Oct 27, 2021
Atellica IM 1600 Analyzer, SMN 11066000
FDA Devices Moderate Oct 27, 2021
Atellica IM 1300 Analyzer, SMN 11066001
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
FDA Devices Moderate Jul 14, 2021
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
FDA Devices Moderate Jul 14, 2021
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.
FDA Devices Moderate Jul 14, 2021
Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
FDA Devices Moderate Jul 14, 2021
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
FDA Devices Moderate Jun 23, 2021
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
FDA Devices Moderate Jun 2, 2021
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
FDA Devices Moderate Apr 28, 2021
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
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