PlainRecalls

Siemens Healthcare Diagnostics, Inc

Compiled from official public sources by the editorial team.

660 recalls on record · Latest: May 6, 2026

Siemens Healthcare Diagnostics, Inc Recall Insight

Siemens Healthcare Diagnostics, Inc appears on 660 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.649% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 6, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 48 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 48 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from May 24, 2017 to May 16, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 …

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 horm…

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 ADVI…

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 …

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

FDA Devices Moderate Jun 28, 2017

Dimension Vista Ferritin (FERR) Flex reagent cartridge

FDA Devices Moderate Jun 28, 2017

Dimension Troponin 1 (TNI) Flex reagent cartridge

FDA Devices Moderate Jun 7, 2017

SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SH…

FDA Devices Moderate May 24, 2017

ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of i…

FDA Devices Moderate May 24, 2017

ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.