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, 48 moderate, and 2 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 Jan 13, 2016 to Sep 21, 2016.

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 Sep 21, 2016

Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392

FDA Devices Moderate Sep 21, 2016

RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393

FDA Devices Moderate Sep 21, 2016

Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 103313…

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 Low Aug 31, 2016

Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use…

FDA Devices Moderate Aug 17, 2016

Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic us…

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 Aug 3, 2016

Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of …

FDA Devices Moderate Jul 27, 2016

ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN …

FDA Devices Moderate Jul 6, 2016

Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab …

FDA Devices Moderate Jun 29, 2016

Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic us…

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 May 18, 2016

Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

FDA Devices Moderate May 18, 2016

Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or pla…

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Enzymatic Creatine (ECRE)

FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Lactate

FDA Devices Low May 18, 2016

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is …

FDA Devices Moderate May 18, 2016

Dimension Assays: Uric Acid (URCA)

FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: LDL Cholesterol, Direct

FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

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…

FDA Devices Moderate Mar 30, 2016

IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product U…

FDA Devices Moderate Mar 30, 2016

Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use i…

FDA Devices Moderate Mar 30, 2016

IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diag…

FDA Devices Moderate Mar 30, 2016

Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test fo…

FDA Devices Moderate Mar 16, 2016

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro…

FDA Devices Moderate Mar 16, 2016

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vi…

FDA Devices Moderate Mar 16, 2016

Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E…

FDA Devices Moderate Mar 9, 2016

Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usag…

FDA Devices Moderate Mar 2, 2016

BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, C…

FDA Devices Moderate Mar 2, 2016

BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED),…

FDA Devices Moderate Feb 10, 2016

ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral…

FDA Devices Moderate Feb 10, 2016

ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usa…

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Cata…

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: C…

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.