Siemens Atellica CH Urine Albumin test recalled for falsely low results
What this means
Siemens Healthcare Diagnostics recalled its Atellica CH Urine Albumin test kits because they may report falsely low results for high-protein urine samples. If a sample contains more than 40.0 mg/dL of albumin, the test may incorrectly show a value between 6.2 and 40.0 mg/dL instead. This affects all lot numbers of Material Number 11537225 distributed worldwide.
- Stop using Atellica CH Urine Albumin test kit (Material Number 11537225) immediately
- Contact Siemens Healthcare Diagnostics for guidance on replacement or refund
- Review recent test results from this kit with your healthcare provider if concerned about accuracy
- Notify your laboratory director or compliance officer if your facility used this product
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.