Siemens Healthcare Diagnostics recalls

Siemens Healthcare Diagnostics has 695 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 7 Oct 2026. 173 are still ongoing. 16 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls695since 2012

Last 12 months16reported

Class I132% of total

Ongoing173latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

3Nov '24 2 9 0Feb 0 1 3May 2 5 2Aug 1 0 4Nov 0 0 0Feb 1 1 2May 1 1 5Aug 0 1

Severity split

Class I 13 2%Class II 639 92%Class III 43 6%

Why siemens healthcare diagnostics is recalled

Product types

By year

2026122%
2025274%
2024254%
2023375%
2022325%
2021446%
2020517%
2019264%
20189213%
2017365%

Ongoing siemens healthcare diagnostics recalls

173 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Atellica CH Revised C-Reactive Protein (RCRP) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit Disopyramide Assay Enzyme Immunoassay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS II	Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit tox Serum Tricyclic Antidepressant recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

All siemens healthcare diagnostics recalls, newest first

695 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Atellica CH Revised C-Reactive Protein (RCRP) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit Disopyramide Assay Enzyme Immunoassay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS II	Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit tox Serum Tricyclic Antidepressant recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
15 Jul 2026Device	CLASS II	Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Jun 2026Device	CLASS II	Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
6 May 2026Device	CLASS II	epoc BGEM BUN Test Card for the epoc Blood Analysis System recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Dimension Creatinine Flex reagent cartridge recalled	Siemens Healthcare Diagnostics	Other	Nationwide
8 Apr 2026Device	CLASS II	Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
11 Mar 2026Device	CLASS II	Atellica CH Urine Albumin (UAlb) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
19 Nov 2025Device	CLASS II	Immulite 2000 Oak Mix Specific Allergen recalled	Siemens Healthcare Diagnostics	Labeling Errors	Nationwide
19 Nov 2025Device	CLASS II	3gAllergy Specific IgE Universal Kit recalled	Siemens Healthcare Diagnostics	Labeling Errors	Nationwide
19 Nov 2025Device	CLASS II	Food Panel 3 Specific Allergen recalled	Siemens Healthcare Diagnostics	Labeling Errors	Nationwide
5 Nov 2025Device	CLASS II	Assay: Immulite 2000 Intact PTH recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
17 Sep 2025Device	CLASS II	Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
13 Aug 2025Device	CLASS II	epoc BGEM BUN Test Card []. Material Number recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS II	RAPIDPoint 500 Systems Wash/Waste Cartridge recalled	Siemens Healthcare Diagnostics	Other	Nationwide
9 Jul 2025Device	CLASS II	Advia¿ 120/2120/2120i SETpoint Calibrator recalled	Siemens Healthcare Diagnostics	Other	Nationwide
9 Jul 2025Device	CLASS II	Advia¿ 120/2120/2120i-1 TESTpoint Control (ABN1 Control) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
9 Jul 2025Device	CLASS II	Advia¿ 120/2120/2120i-1 TESTpoint Control (Norm Control) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
9 Jul 2025Device	CLASS II	Advia¿ 120/2120/2120i-1 TESTpoint Control (ABN2 Control) recalled	Siemens Healthcare Diagnostics	Other	Nationwide
2 Jul 2025Device	CLASS II	Atellica CH Diluent - CONS .; Siemens Material Number (SMN) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
4 Jun 2025Device	CLASS II	Advia Centaur HCY Calibrator recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
4 Jun 2025Device	CLASS II	Atellica IM Homocysteine Calibrator recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
7 May 2025Device	CLASS II	epoc BGEM Crea Test Card for the epoc Blood Analysis System recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
7 May 2025Device	CLASS II	Stratus CS Acute Care cTNI TestPak.IVD test recalled	Siemens Healthcare Diagnostics	Other	Nationwide
7 May 2025Device	CLASS II	epoc BGEM BUN Test Card for the epoc Blood Analysis System recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
16 Apr 2025Device	CLASS II	Atellica CH Revised C Reactive Protein (RCRP) recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.