Brand

Siemens Healthcare Diagnostics, Inc. Recalls

423 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Siemens Healthcare Diagnostics, Inc..

423Total Recalls
14Critical
15.1MUnits Affected
Mar 18, 2026Most Recent
All Recalls

Every Siemens Healthcare Diagnostics, Inc. Recall

Sorted by most recent. Click any recall for full details.

423 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
Medical Devices·197 affected·Mar 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Diagnostic Devices·10,310,443 affected·Feb 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic t...
Diagnostic Devices·6,000 affected·Jan 30, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ DHEA-SO4
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ HBc IgM
Medical Devices·6 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 CEA
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ Cyclosporine
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for...
Diagnostic Devices·0 affected·Nov 27, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stim...
Diagnostic Devices·989 affected·Nov 9, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum us...
Diagnostic Devices·33,298 affected·Jul 28, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transfera...
Diagnostic Devices·33,233 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·19,991 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,056 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (hep...
Diagnostic Devices·7,014 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·181,072 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium h...
Diagnostic Devices·1,667 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diabetes Devices·80,466 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·37,923 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·3,130 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·226 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·32,744 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,067 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·30,446 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Medical Devices·5,992 affected·Jun 7, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Medical Devices·0 affected·May 23, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Medical Devices·0 affected·May 23, 2017
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system test...
Medical Devices·159 affected·Apr 10, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determ...
Diabetes Devices·0 affected·Apr 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Diabetes Devices·0 affected·Apr 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Diagnostic Devices·19 affected·Mar 21, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay ...
Diagnostic Devices·1,900 affected·Mar 8, 2017
RecallFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT...
Diagnostic Devices·314 affected·Feb 23, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuo...
Diagnostic Devices·17 affected·Feb 2, 2017