PlainRecalls

Siemens Healthcare Diagnostics, Inc.

Compiled from official public sources by the publisher.

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

notices

What this shows Siemens Healthcare Diagnostics, Inc. carries 665 distinct federal notices, ranked #6 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Feb 6, 2019

Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Devices Moderate Dec 26, 2018

Dimension Vista 500, model no. 10284473 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 26, 2018

Dimension Vista 1500, Model No. 10444801 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 5, 2018

Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
FDA Devices Moderate Nov 21, 2018

Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
FDA Devices Moderate Nov 21, 2018

Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
FDA Devices Moderate Nov 14, 2018

Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM 00630414949819; Dimension¿ Xpand¿ Plus 00630414949833; Dimension¿ Xpand¿ Plus HM 00630414949840; Dimension¿ RxL Max Refurbished 00630414592947; Dimension¿ RxL Max HM Refurbished 0
FDA Devices Moderate Oct 31, 2018

APTIO 15000 REFRIGERATED STORAGE MODULE
FDA Devices Moderate Oct 31, 2018

APTIO RACK INPUT MODULE
FDA Devices Moderate Oct 31, 2018

STREAMLAB CORE UNIT / LYNX WITH IOM
FDA Devices Moderate Oct 31, 2018

APTIO INPUT/OUTPUT MODULE
FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 9000
FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 15000
FDA Devices Moderate Oct 31, 2018

APTIO RACK OUTPUT MODULE
FDA Devices Moderate Oct 31, 2018

APTIO 9000 REFRIGERATED STORAGE MODULE
FDA Devices Moderate Oct 31, 2018

APTIO CENTRIFUGE MODULE
FDA Devices Moderate Oct 24, 2018

Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018

Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Devices Moderate Oct 24, 2018

Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018

Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Devices Moderate Oct 24, 2018

Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Devices Moderate Oct 24, 2018

Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018

Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018

Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Devices Moderate Sep 5, 2018

RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
FDA Devices Moderate Sep 5, 2018

RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
FDA Devices Moderate Sep 5, 2018

RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
FDA Devices Moderate Sep 5, 2018

RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
FDA Devices Moderate Jun 20, 2018

Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
FDA Devices Moderate Jun 20, 2018

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
FDA Devices Moderate Jun 13, 2018

ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
FDA Devices Moderate Jun 13, 2018

ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
FDA Devices Moderate Jun 13, 2018

ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
FDA Devices Moderate Jun 6, 2018

Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
FDA Devices Moderate May 16, 2018

ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)
FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
FDA Devices Moderate May 16, 2018

ADVIA Centaur¿ DHEA-SO4
FDA Devices Moderate May 16, 2018

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
FDA Devices Moderate May 16, 2018

Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

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).

Icu Medical, Inc. 657 Newly Weds Foods, Inc. 657 Customed, Inc 682 Garden Fresh Foods, Inc. 634 Boston Scientific Corporation 632

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Icu Medical, Inc. 657 Customed, Inc 682 Boston Scientific Corporation 632 Siemens Medical Solutions USA, Inc 796

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