Recall archive / FDA device enforcement
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. — FDA record Z-2937-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 18, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Bioporto Diagnostics A/S
- Quantity
- 400 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2937-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 19, 2026
- Recall initiation date
- May 18, 2026
- Center classification date
- Aug 12, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.