Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

What happened?

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 should I do now?

1Check the lot number on your product packaging.
2If you have it, stop using it.
3Return it to your pharmacy or store for a refund.
4If you already used it and feel unwell, see your doctor immediately.
5Report adverse effects to the FDA: 1-800-FDA-1088.

Company: Siemens Healthcare Diagnostics, Inc.
Status: Ongoing
Report date: 2026-08-12
Initiated: 2026-07-06
Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿
Quantity: 7018 units

This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.