⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Is Siemens Healthcare Diagnostics recalled?

Siemens Healthcare Diagnostics recalls - full list & free alerts

Official U.S. agency records list 16 recalls involving Siemens Healthcare Diagnostics in the last 12 months, most recently on 2026-10-07. Check each official notice for the exact products, lot codes and dates affected.

Check a lot code, UPC or model number

This is not a guarantee; check the official notice.

Recalls (16)

Siemens Healthcare Diagnostics, Inc.: Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Siemens Healthcare Diagnostics, Inc.: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Medical DevicesFDA (device) · 2026-08-26 · 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) · 2026-08-26 · Class II
Siemens Healthcare Diagnostics, Inc.: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Medical DevicesFDA (device) · 2026-08-12 · Class III
Siemens Healthcare Diagnostics, Inc.: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Medical DevicesFDA (device) · 2026-08-12 · Class III
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Medical DevicesFDA (device) · 2026-08-12 · Class II
Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Medical DevicesFDA (device) · 2026-07-15 · Class II
Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Medical DevicesFDA (device) · 2026-06-17 · Class II
Siemens Healthcare Diagnostics, Inc.: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Medical DevicesFDA (device) · 2026-05-06 · 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) · 2026-05-06 · Class II
Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Medical DevicesFDA (device) · 2026-04-08 · Class II
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Medical DevicesFDA (device) · 2026-03-11 · Class II
Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Medical DevicesFDA (device) · 2025-11-19 · 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) · 2025-11-19 · Class II
Siemens Healthcare Diagnostics, Inc.: Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Medical DevicesFDA (device) · 2025-11-19 · 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) · 2025-11-05 · Class II
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.