[pending] Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Pending LLM rewrite. Source: FDA_DEVICE Z-1484-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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