Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Pending LLM rewrite. Source: FDA_DEVICE Z-1484-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
The recalled product
- Product
- Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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