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 Apr 1, 2020 to Apr 21, 2021.

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 Apr 21, 2021

ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and …

FDA Devices Moderate Apr 21, 2021

ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Devices Moderate Apr 21, 2021

ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 a…

FDA Devices Moderate Mar 24, 2021

Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

FDA Devices Moderate Mar 17, 2021

Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellit…

FDA Devices Moderate Jan 20, 2021

Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: inten…

FDA Devices Moderate Jan 20, 2021

Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intend…

FDA Devices Moderate Jan 20, 2021

Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: inten…

FDA Devices Moderate Dec 30, 2020

Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl tr…

FDA Devices Moderate Dec 30, 2020

ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl trans…

FDA Devices Moderate Nov 25, 2020

Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siem…

FDA Devices Moderate Nov 25, 2020

Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Sie…

FDA Devices Moderate Oct 28, 2020

Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline ph…

FDA Devices Moderate Oct 28, 2020

Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)006304145991…

FDA Devices Moderate Oct 21, 2020

ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human s…

FDA Devices Moderate Oct 21, 2020

Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum…

FDA Devices Moderate Oct 14, 2020

Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac trop…

FDA Devices Moderate Sep 23, 2020

Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous o…

FDA Devices Moderate Sep 9, 2020

Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac trop…

FDA Devices Moderate Aug 12, 2020

DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

FDA Devices Moderate Jul 8, 2020

(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software…

FDA Devices Moderate Jul 8, 2020

Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laborato…

FDA Devices Moderate Jul 8, 2020

(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Mate…

FDA Devices Moderate Jul 8, 2020

Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a labo…

FDA Devices Moderate Jul 1, 2020

ADVIA Chemistry Calibrator

FDA Devices Moderate Jul 1, 2020

Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

FDA Devices Moderate Jul 1, 2020

RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778

FDA Devices Moderate Jul 1, 2020

Atellica CH Chemistry Calibrator

FDA Devices Moderate Jul 1, 2020

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

FDA Devices Moderate Jun 17, 2020

ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative mea…

FDA Devices Moderate Jun 17, 2020

Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determinatio…

FDA Devices Moderate Jun 17, 2020

Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated …

FDA Devices Moderate Jun 17, 2020

Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of…

FDA Devices Moderate Jun 17, 2020

Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determinat…

FDA Devices Moderate Jun 17, 2020

ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determin…

FDA Devices Moderate May 6, 2020

Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

FDA Devices Moderate Apr 1, 2020

ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use i…

FDA Devices Moderate Apr 1, 2020

Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: D…

FDA Devices Moderate Apr 1, 2020

Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 ass…

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.