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Siemens Healthcare Diagnostics recalls - full list & free alerts

16 official U.S. recalls involving Siemens Healthcare Diagnostics in the last 12 months, most recently on 2026-10-07.

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Full list (16)

Siemens Healthcare Diagnostics, Inc.: Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Medical DevicesFDA (device) ยท 2026-08-26 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Medical DevicesFDA (device) ยท 2026-08-26 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Medical DevicesFDA (device) ยท 2026-08-12 ยท Class III
Siemens Healthcare Diagnostics, Inc.: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Medical DevicesFDA (device) ยท 2026-08-12 ยท Class III
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Medical DevicesFDA (device) ยท 2026-08-12 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Medical DevicesFDA (device) ยท 2026-07-15 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Medical DevicesFDA (device) ยท 2026-06-17 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Medical DevicesFDA (device) ยท 2026-05-06 ยท Class II
Siemens Healthcare Diagnostics Inc: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Medical DevicesFDA (device) ยท 2026-05-06 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Medical DevicesFDA (device) ยท 2026-03-11 ยท Class II
Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Medical DevicesFDA (device) ยท 2025-11-19 ยท Class II
Siemens Healthcare Diagnostics, Inc.: 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Anti
Medical DevicesFDA (device) ยท 2025-11-19 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Medical DevicesFDA (device) ยท 2025-11-19 ยท Class II
Siemens Healthcare Diagnostics, Inc.: Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (
Medical DevicesFDA (device) ยท 2025-11-05 ยท Class II