ProductGuru Recalls

Brand

Siemens Healthcare Diagnostics, Inc.: official recall notices

29 official recall or safety notices on this site name Siemens Healthcare Diagnostics, Inc., dated between 2024-01-24 and 2026-07-13. They were issued by 1 authority: US FDA — Medical Devices (29).

Countries where the notices were issued: United States (29).

Name as written in the notices: Siemens Healthcare Diagnostics, Inc.; Siemens Healthcare Diagnostics Inc. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

Notices by year

YearNotices
20267
20255
202417

Notices by authority

AuthorityNotices
US FDA — Medical Devices29

All notices

DateAuthorityProductHazard (as classified)
2026-07-13US FDA — Medical DevicesBeckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL—
2026-07-13US FDA — Medical DevicesSyva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL—
2026-07-06US FDA — Medical DevicesAtellica CH Urine Albumin REF: 11537225, in vitro diagnostic—
2026-06-26US FDA — Medical DevicesSyva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL—
2026-06-26US FDA — Medical DevicesSyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL—
2026-03-18US FDA — Medical DevicesDimension Creatinine Flex reagent cartridge. Material Number: 10872079.—
2026-02-23US FDA — Medical DevicesAtellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;—
2025-10-06US FDA — Medical DevicesFood Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;—
2025-10-06US FDA — Medical Devices3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci—
2025-10-06US FDA — Medical DevicesIMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;—
2025-07-07US FDA — Medical Devicesepoc BGEM BUN Test Card [25pk]. Material Number: 10736515.—
2025-06-26US FDA — Medical DevicesRAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.—
2024-11-22US FDA — Medical Devicesepoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra—
2024-11-22US FDA — Medical Devicesepoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra—
2024-11-22US FDA — Medical Devicesepoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t—
2024-11-22US FDA — Medical Devicesepoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train—
2024-11-22US FDA — Medical Devicesepoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra—
2024-11-12US FDA — Medical DevicesMagnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;—
2024-11-04US FDA — Medical DevicesAtellica CI Analyzer. Catalog Numbers: 10947347.—
2024-09-24US FDA — Medical Devicesepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515—
2024-08-15US FDA — Medical DevicesAtellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human—
2024-07-30US FDA — Medical DevicesDimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;—
2024-07-26US FDA — Medical DevicesAtellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an—
2024-07-26US FDA — Medical DevicesADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated—
2024-07-26US FDA — Medical DevicesAtellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ—
2024-07-26US FDA — Medical DevicesADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated—
2024-05-17US FDA — Medical DevicesSoftware version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e—
2024-03-13US FDA — Medical DevicesAtellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu—
2024-01-24US FDA — Medical DevicesAtellica IM Erythropoietin (EPO) Assay (100 Test)—

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