Z-2937-2026 Class II Ongoing
FDA device recall Z-2937-2026 was initiated by Bioporto Diagnostics A/S on May 18, 2026 and is designated Class II. Reason for recall: The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in … The recall status is ongoing. Affected quantity: 400 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- May 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 units
Product Description
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Reason for Recall
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
Distribution Pattern
Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada.
Code Information
Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.