Atlas FDA

Siemens Healthcare Diagnostics, Inc.

465 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Siemens Healthcare Diagnostics, Inc.

RecordFirmDate
Atellica CH Urine Albumin REF: 11537225 recall (Z-2890-2026)Siemens Healthcare Diagnostics, Inc.2026-08-05
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL recall (Z-2880-2026)Siemens Healthcare Diagnostics, Inc.2026-08-04
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. recall (Z-2881-2026)Siemens Healthcare Diagnostics, Inc.2026-08-04
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. recall (Z-2703-2026)Siemens Healthcare Diagnostics, Inc.2026-07-08
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme recall (Z-2398-2026)Siemens Healthcare Diagnostics, Inc.2026-06-10
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Numbe recall (Z-2005-2026)Siemens Healthcare Diagnostics Inc2026-04-29
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. recall (Z-1980-2026)Siemens Healthcare Diagnostics, Inc.2026-04-28
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; recall (Z-1657-2026)Siemens Healthcare Diagnostics, Inc.2026-03-27
Atellica CH Urine Albumin (UAlb). Material Number: 11537225 recall (Z-1484-2026)Siemens Healthcare Diagnostics, Inc.2026-03-02
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog recall (Z-0491-2026)Siemens Healthcare Diagnostics, Inc.2025-11-13
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antib recall (Z-0492-2026)Siemens Healthcare Diagnostics, Inc.2025-11-13
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: F recall (Z-0493-2026)Siemens Healthcare Diagnostics, Inc.2025-11-13
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 103814 recall (Z-0366-2026)Siemens Healthcare Diagnostics, Inc.2025-10-27
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. recall (Z-2542-2025)Siemens Healthcare Diagnostics, Inc.2025-09-08
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. recall (Z-2272-2025)Siemens Healthcare Diagnostics Inc2025-08-05
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. recall (Z-2230-2025)Siemens Healthcare Diagnostics Inc2025-07-31
ADVIA 120/2120/2120i SETpoint Calibrator recall (Z-2086-2025)Siemens Healthcare Diagnostics, Inc.2025-07-03
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) recall (Z-2087-2025)Siemens Healthcare Diagnostics, Inc.2025-07-03
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) recall (Z-2088-2025)Siemens Healthcare Diagnostics, Inc.2025-07-03
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) recall (Z-2089-2025)Siemens Healthcare Diagnostics, Inc.2025-07-03
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; recall (Z-2027-2025)Siemens Healthcare Diagnostics, Inc.2025-06-25
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 recall (Z-1821-2025)Siemens Healthcare Diagnostics, Inc.2025-05-27
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. recall (Z-1822-2025)Siemens Healthcare Diagnostics, Inc.2025-05-27
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Numbe recall (Z-1684-2025)Siemens Healthcare Diagnostics Inc2025-04-29
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Numb recall (Z-1685-2025)Siemens Healthcare Diagnostics Inc2025-04-29
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. recall (Z-1673-2025)Siemens Healthcare Diagnostics Inc2025-04-25
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. recall (Z-1551-2025)Siemens Healthcare Diagnostics, Inc.2025-04-10
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Numbe recall (Z-0767-2025)Siemens Healthcare Diagnostics, Inc.2024-12-26
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14 recall (Z-0734-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14 recall (Z-0735-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14 recall (Z-0736-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14 recall (Z-0737-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14 recall (Z-0738-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4. recall (Z-0739-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: recall (Z-0740-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14 recall (Z-0741-2025)Siemens Healthcare Diagnostics, Inc.2024-12-20
Atellica CI Analyzer. Catalog Numbers: 10947347. recall (Z-0597-2025)Siemens Healthcare Diagnostics, Inc.2024-12-04
Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determinat recall (Z-0599-2025)Siemens Healthcare Diagnostics, Inc.2024-12-04
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate t recall (Z-0496-2025)Siemens Healthcare Diagnostics, Inc.2024-11-20
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPT recall (Z-0464-2025)Siemens Healthcare Diagnostics, Inc.2024-11-14
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 recall (Z-0286-2025)Siemens Healthcare Diagnostics Inc2024-11-01
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) recall (Z-3304-2024)Siemens Healthcare Diagnostics, Inc.2024-09-27
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) recall (Z-3305-2024)Siemens Healthcare Diagnostics, Inc.2024-09-27
Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measure recall (Z-3169-2024)Siemens Healthcare Diagnostics, Inc.2024-09-18
ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative me recall (Z-3170-2024)Siemens Healthcare Diagnostics, Inc.2024-09-18
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of t recall (Z-3100-2024)Siemens Healthcare Diagnostics, Inc.2024-09-11
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of recall (Z-3101-2024)Siemens Healthcare Diagnostics, Inc.2024-09-11
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measureme recall (Z-3102-2024)Siemens Healthcare Diagnostics, Inc.2024-09-11
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of recall (Z-3103-2024)Siemens Healthcare Diagnostics, Inc.2024-09-11
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement o recall (Z-3104-2024)Siemens Healthcare Diagnostics, Inc.2024-09-11
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 110 recall (Z-3063-2024)Siemens Healthcare Diagnostics, Inc.2024-09-06
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): recall (Z-3064-2024)Siemens Healthcare Diagnostics, Inc.2024-09-06
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SM recall (Z-3065-2024)Siemens Healthcare Diagnostics, Inc.2024-09-06
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 1 recall (Z-2214-2024)Siemens Healthcare Diagnostics Inc2024-06-26
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid recall (Z-1886-2024)Siemens Healthcare Diagnostics, Inc.2024-05-23
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid recall (Z-1887-2024)Siemens Healthcare Diagnostics, Inc.2024-05-23
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and pla recall (Z-1549-2024)Siemens Healthcare Diagnostics, Inc.2024-04-16
DCA Systems HbA1c Reagent Kit recall (Z-1304-2024)Siemens Healthcare Diagnostics, Inc.2024-03-19
Atellica IM Erythropoietin (EPO) Assay (100 Test) recall (Z-1280-2024)Siemens Healthcare Diagnostics, Inc.2024-03-11
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) recall (Z-1281-2024)Siemens Healthcare Diagnostics, Inc.2024-03-11
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry recall (Z-1003-2024)Siemens Healthcare Diagnostics, Inc.2024-02-07
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US) recall (Z-0601-2024)Siemens Healthcare Diagnostics Inc2023-12-21
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro dia recall (Z-0606-2024)Siemens Healthcare Diagnostics Inc2023-12-21
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diag recall (Z-0607-2024)Siemens Healthcare Diagnostics Inc2023-12-21
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diag recall (Z-0608-2024)Siemens Healthcare Diagnostics Inc2023-12-21
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diag recall (Z-0609-2024)Siemens Healthcare Diagnostics Inc2023-12-21
RAPIDPOINT 500e Blood Gas System recall (Z-0422-2024)Siemens Healthcare Diagnostics Inc2023-12-01
RAPIDPOINT 500 Blood Gas System recall (Z-0423-2024)Siemens Healthcare Diagnostics Inc2023-12-01
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10 recall (Z-2666-2023)Siemens Healthcare Diagnostics, Inc.2023-09-30
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination o recall (Z-1268-2023)Siemens Healthcare Diagnostics, Inc.2023-08-29
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of recall (Z-1269-2023)Siemens Healthcare Diagnostics, Inc.2023-08-29
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measu recall (Z-1270-2023)Siemens Healthcare Diagnostics, Inc.2023-08-29
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of recall (Z-1271-2023)Siemens Healthcare Diagnostics, Inc.2023-08-29
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination o recall (Z-2471-2023)Siemens Healthcare Diagnostics, Inc.2023-08-28
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of recall (Z-2472-2023)Siemens Healthcare Diagnostics, Inc.2023-08-28
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determ recall (Z-2473-2023)Siemens Healthcare Diagnostics, Inc.2023-08-28
Atellica CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of recall (Z-2474-2023)Siemens Healthcare Diagnostics, Inc.2023-08-28
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configurati recall (Z-2476-2023)Siemens Healthcare Diagnostics Inc2023-08-28
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configurat recall (Z-2477-2023)Siemens Healthcare Diagnostics Inc2023-08-28
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6 recall (Z-2478-2023)Siemens Healthcare Diagnostics Inc2023-08-28
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in v recall (Z-2451-2023)Siemens Healthcare Diagnostics, Inc.2023-08-24
Aptio Automation Storage and Retrieval Module (SRM) recall (Z-2091-2023)Siemens Healthcare Diagnostics, Inc.2023-07-05
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethan recall (Z-1631-2023)Siemens Healthcare Diagnostics, Inc.2023-05-25
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL recall (Z-1632-2023)Siemens Healthcare Diagnostics, Inc.2023-05-25
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and recall (Z-1504-2023)Siemens Healthcare Diagnostics, Inc.2023-05-03
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Materi recall (Z-1505-2023)Siemens Healthcare Diagnostics, Inc.2023-05-03
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantit recall (Z-1258-2023)Siemens Healthcare Diagnostics, Inc.2023-03-15
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc H recall (Z-1214-2023)Siemens Healthcare Diagnostics Inc2023-03-03
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 recall (Z-1215-2023)Siemens Healthcare Diagnostics Inc2023-03-03
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determina recall (Z-1149-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determina recall (Z-1150-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative dete recall (Z-1151-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determin recall (Z-1152-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determi recall (Z-1153-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative de recall (Z-1154-2023)Siemens Healthcare Diagnostics, Inc.2023-02-21
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoas recall (Z-1143-2023)Siemens Healthcare Diagnostics, Inc.2023-02-17
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Syste recall (Z-0949-2023)Siemens Healthcare Diagnostics, Inc.2023-01-11
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Syst recall (Z-0950-2023)Siemens Healthcare Diagnostics, Inc.2023-01-11
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Mater recall (Z-0716-2023)Siemens Healthcare Diagnostics, Inc.2022-12-15
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens recall (Z-0717-2023)Siemens Healthcare Diagnostics, Inc.2022-12-15
Next →

Track Siemens Healthcare Diagnostics, Inc. automatically

Every clearance here is in the API, with alerts when new ones post.