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, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 45 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 29, 2024 to May 6, 2026.

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 6, 2026

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

FDA Devices Moderate May 6, 2026

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

FDA Devices Moderate Apr 8, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

FDA Devices Moderate Mar 11, 2026

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

FDA Devices Moderate Nov 19, 2025

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

FDA Devices Moderate Nov 19, 2025

3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2U…

FDA Devices Moderate Nov 19, 2025

IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

FDA Devices Moderate Nov 5, 2025

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

FDA Devices Moderate Sep 17, 2025

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

FDA Devices Moderate Aug 13, 2025

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

FDA Devices Moderate Aug 6, 2025

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i SETpoint Calibrator

FDA Devices Moderate Jul 2, 2025

Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

FDA Devices Moderate Jun 4, 2025

Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

FDA Devices Moderate Jun 4, 2025

ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

FDA Devices Moderate May 7, 2025

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configura…

FDA Devices Moderate May 7, 2025

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

FDA Devices Moderate May 7, 2025

epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configur…

FDA Devices Moderate Apr 16, 2025

Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

FDA Devices Moderate Jan 1, 2025

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals …

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as a…

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professional…

FDA Devices Moderate Dec 11, 2024

Atellica CI Analyzer. Catalog Numbers: 10947347.

FDA Devices Moderate Dec 11, 2024

Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Sieme…

FDA Devices Moderate Nov 27, 2024

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each process…

FDA Devices Moderate Nov 20, 2024

IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

FDA Devices Moderate Nov 13, 2024

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

FDA Devices Moderate Oct 9, 2024

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

FDA Devices Moderate Oct 9, 2024

ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

FDA Devices Moderate Sep 25, 2024

Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry sys…

FDA Devices Moderate Sep 25, 2024

ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistr…

FDA Devices Moderate Sep 18, 2024

Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using th…

FDA Devices Moderate Sep 18, 2024

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

FDA Devices Moderate Sep 18, 2024

Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

FDA Devices Moderate Sep 18, 2024

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

FDA Devices Moderate Sep 18, 2024

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using …

FDA Devices Moderate Sep 18, 2024

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum u…

FDA Devices Moderate Sep 18, 2024

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using…

FDA Devices Moderate Sep 18, 2024

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using …

FDA Devices Moderate Jul 3, 2024

Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 114…

FDA Devices Moderate May 29, 2024

IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Siemens Healthcare Diagnostics, Inc with Zimmer Biomet, Inc. →

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.