FDA DevicesClass II
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Published: March 11, 2026Recall ID: Z-1484-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Additional Source Details
| Field | Value |
|---|---|
| City | Tarrytown |
| State | NY |
| Event id | 98370 |
| Address 1 | 511 Benedict Ave |
| Address 2 | N/A |
| Code info | Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers. |
| Postal code | 10591-5005 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 4,885 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260120 |
| Initial firm notification | Letter |
| Center classification date | 20260302 |
Overview
- Recalling FirmSiemens Healthcare Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.