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 Nov 21, 2018 to Apr 1, 2020.

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 1, 2020

Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

FDA Devices Moderate Apr 1, 2020

ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in t…

FDA Devices Moderate Apr 1, 2020

Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product …

FDA Devices Moderate Apr 1, 2020

Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is f…

FDA Devices Moderate Mar 25, 2020

IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - P…

FDA Devices Moderate Mar 25, 2020

IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Ana…

FDA Devices Moderate Mar 11, 2020

Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for t…

FDA Devices Moderate Mar 11, 2020

Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is…

FDA Devices Moderate Mar 11, 2020

Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

FDA Devices Moderate Mar 4, 2020

ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are us…

FDA Devices Moderate Feb 26, 2020

Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

FDA Devices Moderate Feb 26, 2020

ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of…

FDA Devices Moderate Feb 26, 2020

Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistr…

FDA Devices Moderate Feb 26, 2020

Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

FDA Devices Moderate Feb 26, 2020

Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520

FDA Devices Moderate Feb 26, 2020

ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869

FDA Devices Moderate Feb 5, 2020

Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, cli…

FDA Devices Moderate Jan 29, 2020

Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308

FDA Devices Moderate Jan 29, 2020

Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366

FDA Devices Moderate Jan 29, 2020

Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

FDA Devices Moderate Dec 4, 2019

Atellica CH 930 Analyzer

FDA Devices Moderate Oct 30, 2019

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

FDA Devices Moderate Oct 30, 2019

Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

FDA Devices Moderate Oct 23, 2019

Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in …

FDA Devices Moderate Oct 2, 2019

Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG…

FDA Devices Moderate Aug 28, 2019

IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

FDA Devices Moderate Aug 28, 2019

N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Materi…

FDA Devices Moderate Aug 28, 2019

IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170

FDA Devices Moderate Aug 14, 2019

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimensio…

FDA Devices Moderate Aug 7, 2019

Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized…

FDA Devices Moderate Jul 10, 2019

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kina…

FDA Devices Moderate Jul 10, 2019

Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (…

FDA Devices Moderate May 15, 2019

Atellica IM 1600 Analyzer, Material Number 11066000

FDA Devices Moderate May 15, 2019

Atellica Sample Handler Prime, Material Number 11069001

FDA Devices Moderate May 15, 2019

Atellica IM 1300 Analyzer, Material Number 11066001

FDA Devices Moderate May 8, 2019

SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399

FDA Devices Moderate May 8, 2019

Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461

FDA Devices Moderate May 8, 2019

Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462

FDA Devices Moderate May 8, 2019

Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398

FDA Devices Moderate Apr 24, 2019

syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analy…

FDA Devices Moderate Mar 27, 2019

Dimension Vista 1500, Analyzer, chemistry Model no. 10444801

FDA Devices Moderate Mar 27, 2019

Dimension Vista 500, Analyzer, chemistry Model no. 10284473

FDA Devices Moderate Feb 6, 2019

Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica …

FDA Devices Moderate Feb 6, 2019

Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica S…

FDA Devices Moderate Feb 6, 2019

Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for …

FDA Devices Moderate Feb 6, 2019

Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atel…

FDA Devices Moderate Dec 26, 2018

Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, h…

FDA Devices Moderate Dec 26, 2018

Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, …

FDA Devices Moderate Dec 5, 2018

Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydroge…

FDA Devices Moderate Nov 21, 2018

Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic t…

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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.