Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
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 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 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 May 15, 2019
Atellica IM 1600 Analyzer, Material Number 11066000
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 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 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 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…
FDA Devices Moderate Nov 21, 2018
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the …
FDA Devices Moderate Nov 14, 2018
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM…
FDA Devices Moderate Oct 31, 2018
APTIO 15000 REFRIGERATED STORAGE MODULE
FDA Devices Moderate Oct 31, 2018
APTIO RACK INPUT MODULE
FDA Devices Moderate Oct 31, 2018
STREAMLAB CORE UNIT / LYNX WITH IOM
FDA Devices Moderate Oct 31, 2018
APTIO INPUT/OUTPUT MODULE
FDA Devices Moderate Oct 31, 2018
STREAMLAB - REFRIGERATED STORAGE MODULE 9000
FDA Devices Moderate Oct 31, 2018
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
FDA Devices Moderate Oct 31, 2018
APTIO RACK OUTPUT MODULE
FDA Devices Moderate Oct 24, 2018
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical speci…
FDA Devices Moderate Oct 24, 2018
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This mate…
FDA Devices Moderate Oct 24, 2018
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical …
FDA Devices Moderate Oct 24, 2018
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Devices Moderate Oct 24, 2018
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay…
FDA Devices Moderate Oct 24, 2018
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical speci…
FDA Devices Moderate Oct 24, 2018
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Oct 24, 2018
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Devices Moderate Sep 5, 2018
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's…
FDA Devices Moderate Sep 5, 2018
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's …
FDA Devices Moderate Sep 5, 2018
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to …
FDA Devices Moderate Jul 25, 2018
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
FDA Devices Moderate Jul 25, 2018
Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
FDA Devices Moderate Jun 20, 2018
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
FDA Devices Moderate Jun 20, 2018
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 172…
FDA Devices Moderate Jun 13, 2018
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
FDA Devices Moderate Jun 13, 2018
ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
FDA Devices Moderate Jun 6, 2018