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 50 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 16, 2018 to Nov 21, 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 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 …

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…

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 speci…

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 mate…

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 …

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…

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 speci…

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 ass…

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…

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…

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 …

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 …

FDA Devices Moderate Sep 5, 2018

RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 …

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, 172…

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 …

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) (al…

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)

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…

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). Pro…

FDA Devices Moderate May 16, 2018

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

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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.