Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
FDA Devices Moderate May 16, 2018
IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
FDA Devices Moderate May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
FDA Devices Moderate May 16, 2018
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (al…
FDA Devices Moderate May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
FDA Devices Moderate May 16, 2018
ADVIA Centaur¿ DHEA-SO4
FDA Devices Moderate May 16, 2018
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
FDA Devices Moderate May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
FDA Devices Moderate May 16, 2018
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA…
FDA Devices Moderate May 16, 2018
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Pro…
FDA Devices Moderate May 16, 2018
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
ADVIA Centaur¿ HBc IgM
FDA Devices Moderate May 16, 2018
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 CEA
FDA Devices Moderate May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
FDA Devices Moderate May 16, 2018
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
FDA Devices Moderate May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
FDA Devices Moderate May 16, 2018
ADVIA Centaur¿ Cyclosporine
FDA Devices Moderate May 16, 2018
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
FDA Devices Moderate May 16, 2018
Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Devices Moderate May 9, 2018
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the …
FDA Devices Moderate May 9, 2018
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate May 9, 2018
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate May 9, 2018
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate May 2, 2018
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
FDA Devices Moderate Apr 4, 2018
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating horm…
FDA Devices Moderate Mar 7, 2018
ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVI…
FDA Devices Moderate Feb 14, 2018
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
FDA Devices Moderate Dec 6, 2017
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
FDA Devices Moderate Dec 6, 2017
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
FDA Devices Moderate Jun 28, 2017
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
FDA Devices Moderate May 24, 2017
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of i…
FDA Devices Moderate May 24, 2017
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
FDA Devices Moderate May 17, 2017
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gase…
FDA Devices Moderate Apr 12, 2017
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 is an in vit…
FDA Devices Low Apr 12, 2017
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, …
FDA Devices Moderate Apr 5, 2017
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical…
FDA Devices Moderate Mar 29, 2017
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, continuous operation…
FDA Devices Moderate Mar 15, 2017