Z-1484-2026 Class II Ongoing
FDA device recall Z-1484-2026 was initiated by Siemens Healthcare Diagnostics, Inc. on January 20, 2026 and is designated Class II. 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/… The recall status is ongoing. Affected quantity: 4,885 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- January 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,885 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide 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.