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 May 16, 2018

ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
FDA Devices Moderate May 16, 2018

Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018

ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
FDA Devices Moderate May 16, 2018

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018

Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

ADVIA Centaur¿ HBc IgM
FDA Devices Moderate May 16, 2018

Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

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

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

Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018

Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018

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

ADVIA Centaur¿ Cyclosporine
FDA Devices Moderate May 16, 2018

Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
FDA Devices Moderate May 16, 2018

Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
FDA Devices Moderate May 16, 2018

Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
FDA Devices Moderate May 16, 2018

Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018

Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
FDA Devices Moderate May 16, 2018

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

Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
FDA Devices Low May 16, 2018

Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
FDA Devices Moderate May 16, 2018

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

Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Low May 16, 2018

Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
FDA Devices Moderate May 16, 2018

Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018

ADVIA Centaur¿ Folate (FOL)
FDA Devices Moderate May 9, 2018

Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
FDA Devices Moderate May 9, 2018

Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate May 9, 2018

Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate May 9, 2018

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate May 2, 2018

ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
FDA Devices Moderate Apr 4, 2018

Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
FDA Devices Moderate Mar 7, 2018

ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease.
FDA Devices Moderate Feb 14, 2018

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
FDA Devices Moderate Dec 6, 2017

Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
FDA Devices Moderate Dec 6, 2017

Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
FDA Devices Moderate Dec 6, 2017

Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
FDA Devices Moderate Dec 6, 2017

Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
FDA Devices Moderate Jun 28, 2017

Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
FDA Devices Moderate Jun 28, 2017

Dimension Vista Prolactin (PRL) Flex reagent cartridge
FDA Devices Moderate Jun 28, 2017

Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
FDA Devices Moderate Jun 28, 2017

Dimension Vista Estradiol (E2) Flex reagent cartridge

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