Siemens Healthcare Diagnostics, Inc. 2026-08-12 Health serious FDA
Health · FDA · Recall #FDA-Z-2890-2026
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic Recall
Issued August 12, 2026 · Siemens Healthcare Diagnostics, Inc.
In August 2026, Siemens Healthcare Diagnostics, Inc. recalled the Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
What you should do
- 1 Stop using Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Healthcare Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Siemens Healthcare Diagnostics, Inc.
- Category
- Health
- Recall date
- August 12, 2026
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chil
- Recall number
- FDA-Z-2890-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Healthcare Diagnostics, Inc. has 10 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.