Siemens Healthcare Diagnostics, Inc
East Walpole, MA
This page shows every FDA and USDA recall linked to Siemens Healthcare Diagnostics, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
163
Total Recalls
2008
First Recall
2025
Most Recent
Food Panel 3 Specific Allergen;
Siemens Material Number (SMN): 10385891;
Catalog Number: FP3L4;
Nov 13, 2025
· Device
Open, Classified
IMMULITE 2000 Oak Mix Specific Allergen;
Siemens Material Number (SMN): 10386105;
Catalog Number: L2KUN6;
Nov 13, 2025
· Device
Open, Classified
3gAllergy Specific IgE Universal Kit;
Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAlle...
Nov 13, 2025
· Device
Open, Classified
Assay: IMMULITE 2000 Intact PTH;
Test Code: iPT;
Siemens Material Number (SMN): (1) 10381441, (2) 10381442;
Ca...
Oct 27, 2025
· Device
Open, Classified
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
May 27, 2025
· Device
Open, Classified
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
May 27, 2025
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9.
Intended for us...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9.
Intended for use...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9.
Intended for...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9.
Intended for us...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9.
Intended for us...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9.
Intended for us...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9.
Intended for us...
Dec 20, 2024
· Device
Open, Classified
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9.
Intended fo...
Dec 20, 2024
· Device
Open, Classified
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Nov 14, 2024
· Device
Open, Classified
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-ass...
Sep 11, 2024
· Device
Open, Classified
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-a...
Sep 11, 2024
· Device
Open, Classified
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tu...
Sep 11, 2024
· Device
Open, Classified
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-...
Sep 11, 2024
· Device
Open, Classified
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-a...
Sep 11, 2024
· Device
Open, Classified
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
May 23, 2024
· Device
Open, Classified
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
May 23, 2024
· Device
Open, Classified
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folat...
Feb 21, 2023
· Device
Open, Classified
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in hu...
Feb 21, 2023
· Device
Open, Classified
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate...
Feb 21, 2023
· Device
Open, Classified
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in h...
Feb 21, 2023
· Device
Open, Classified
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in...
Feb 21, 2023
· Device
Open, Classified
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in hu...
Feb 21, 2023
· Device
Open, Classified
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitat...
Feb 17, 2023
· Device
Open, Classified
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US.
Siemens Material Number (SMN): 1...
Dec 15, 2022
· Device
Open, Classified
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan
Siemens Material Number (SMN): 107119...
Dec 15, 2022
· Device
Open, Classified
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan
Siemens Material Number (...
Dec 15, 2022
· Device
Open, Classified
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 10...
Dec 2, 2022
· Device
Open, Classified
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)
Siemens Material Number (SMN): 1...
Sep 27, 2022
· Device
Open, Classified
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of...
Mar 3, 2022
· Device
Open, Classified
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of est...
Mar 3, 2022
· Device
Open, Classified
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estra...
Mar 3, 2022
· Device
Open, Classified
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of e...
Mar 3, 2022
· Device
Open, Classified
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of est...
Mar 3, 2022
· Device
Open, Classified
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estra...
Mar 3, 2022
· Device
Open, Classified
Atellica IM 1600 Analyzer, SMN 11066000
Sep 28, 2021
· Device
Open, Classified
Atellica IM 1300 Analyzer, SMN 11066001
Sep 28, 2021
· Device
Open, Classified
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Sep 22, 2021
· Device
Terminated
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Sep 22, 2021
· Device
Terminated
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination...
Jul 6, 2021
· Device
Open, Classified
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial d...
Jul 6, 2021
· Device
Open, Classified
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination...
Jul 6, 2021
· Device
Open, Classified
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative deter...
Apr 21, 2021
· Device
Open, Classified
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Mar 18, 2021
· Device
Terminated
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:
(01)00630414599151(10)98...
Aug 25, 2020
· Device
Terminated