PlainRecalls

Siemens Healthcare Diagnostics, Inc.

439 recalls on record · Latest: Mar 11, 2026

Siemens Healthcare Diagnostics, Inc. Recall Insight

Siemens Healthcare Diagnostics, Inc. appears on 439 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.523% 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 Mar 11, 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, 46 moderate, and 4 lower-severity recalls. Affected-unit counts are disclosed on 49 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 27, 2016 to Mar 15, 2017.

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 Mar 15, 2017

IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with th…

FDA Devices Moderate Mar 15, 2017

Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the qua…

FDA Devices Moderate Mar 15, 2017

ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quan…

FDA Devices Moderate Mar 8, 2017

Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …

FDA Devices Moderate Mar 8, 2017

Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …

FDA Devices Moderate Mar 8, 2017

Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …

FDA Devices Low Feb 22, 2017

The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For …

FDA Devices Low Feb 22, 2017

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransfer…

FDA Devices Moderate Feb 15, 2017

Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammon…

FDA Devices Moderate Feb 8, 2017

IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagno…

FDA Devices Moderate Dec 28, 2016

IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog…

FDA Devices Moderate Dec 14, 2016

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

FDA Devices Moderate Nov 30, 2016

Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Ch…

FDA Devices Moderate Nov 23, 2016

ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Sie…

FDA Devices Moderate Nov 23, 2016

Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_…

FDA Devices Moderate Nov 23, 2016

ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Sie…

FDA Devices Low Nov 23, 2016

Dimension Vista IRON Flex reagent cartridges

FDA Devices Moderate Nov 23, 2016

Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)

FDA Devices Low Nov 23, 2016

Dimension IRON Flex reagent cartridges

FDA Devices Moderate Nov 23, 2016

Aptio Automation Modules

FDA Devices Moderate Nov 23, 2016

Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)

FDA Devices Moderate Nov 2, 2016

IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique …

FDA Devices Moderate Oct 19, 2016

SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/C…

FDA Devices Moderate Oct 19, 2016

ADVIA Centaur XPT Immunoassay System

FDA Devices Moderate Oct 19, 2016

SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device…

FDA Devices Moderate Oct 12, 2016

Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB

FDA Devices Moderate Oct 5, 2016

Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl …

FDA Devices Moderate Sep 21, 2016

Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 1032123…

FDA Devices Moderate Sep 21, 2016

RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395

FDA Devices Moderate Sep 21, 2016

RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394

FDA Devices Moderate Sep 21, 2016

Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306

FDA Devices Moderate Sep 14, 2016

ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

FDA Devices Moderate Sep 7, 2016

ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when …

FDA Devices Moderate Aug 3, 2016

ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human …

FDA Devices Moderate Jun 8, 2016

Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lot…

FDA Devices Moderate Jun 8, 2016

Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lo…

FDA Devices Moderate May 25, 2016

ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of tri…

FDA Devices Moderate May 18, 2016

Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of…

FDA Devices Moderate May 18, 2016

Dimension Assays: Triglycerides (TGL)

FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

FDA Devices Moderate May 18, 2016

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO metho…

FDA Devices Moderate May 18, 2016

Dimension Assays: ENZYMATIC CREATININE

FDA Devices Moderate May 18, 2016

Dimension Assays: Direct HDL Cholesterol (AHDL)

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Triglycerides (TRIG)

FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Uric Acid (URCA)

FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

FDA Devices Moderate Apr 27, 2016

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hemat…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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