Siemens Healthcare Diagnostics, Inc. — Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 6, 2026
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.¿
What's affected?
- Product
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- Lot code
- within
Additional details
All Lots within expiry/UDI: 00630414611099
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7018 units.
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