Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate Jul 12, 2023
Aptio Automation Storage and Retrieval Module (SRM)
FDA Devices Moderate May 31, 2023
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, …
FDA Devices Moderate May 31, 2023
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salic…
FDA Devices Moderate May 10, 2023
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic us…
FDA Devices Moderate May 10, 2023
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (M…
FDA Devices Moderate Mar 15, 2023
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, …
FDA Devices Moderate Mar 1, 2023
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens…
FDA Devices Moderate Mar 1, 2023
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e an…
FDA Devices Moderate Mar 1, 2023
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Si…
FDA Devices Moderate Jan 18, 2023
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the q…
FDA Devices Moderate Dec 21, 2022
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement…
FDA Devices Moderate Dec 21, 2022
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use w…
FDA Devices Moderate Oct 26, 2022
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3…
FDA Devices Moderate Oct 26, 2022
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
FDA Devices Moderate Oct 26, 2022
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
FDA Devices Moderate Oct 26, 2022
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
FDA Devices Moderate Oct 26, 2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
FDA Devices Moderate Sep 7, 2022
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN…
FDA Devices Moderate Aug 10, 2022
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma sam…
FDA Devices Moderate Jul 20, 2022
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arteri…
FDA Devices Moderate Jul 13, 2022
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in t…
FDA Devices Moderate Jul 13, 2022
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in th…
FDA Devices Moderate Jun 15, 2022
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Nu…
FDA Devices Moderate Jun 15, 2022
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Num…
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
FDA Devices Moderate May 11, 2022
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
FDA Devices Moderate May 11, 2022
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
FDA Devices Moderate May 4, 2022
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Devices Moderate Apr 20, 2022
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
FDA Devices Moderate Apr 20, 2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
FDA Devices Moderate Apr 20, 2022
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
FDA Devices Moderate Apr 6, 2022
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimen…
FDA Devices Moderate Jan 5, 2022
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and pla…
FDA Devices Moderate Dec 8, 2021
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring …
FDA Devices Moderate Dec 8, 2021
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring …
FDA Devices Moderate Nov 10, 2021
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
FDA Devices Moderate Nov 10, 2021
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
FDA Devices Moderate Nov 10, 2021
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
FDA Devices Moderate Nov 3, 2021
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
FDA Devices Moderate Oct 27, 2021
Atellica IM 1600 Analyzer, SMN 11066000
FDA Devices Moderate Oct 27, 2021
Atellica IM 1300 Analyzer, SMN 11066001
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human se…
FDA Devices Moderate Sep 15, 2021
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29…
FDA Devices Moderate Jul 14, 2021
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
FDA Devices Moderate Jul 14, 2021
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on ser…
FDA Devices Moderate Jun 23, 2021
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
FDA Devices Moderate Jun 2, 2021
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pal…
FDA Devices Moderate Apr 28, 2021
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulat…
FDA Devices Moderate Apr 21, 2021