FDA Device recall Z-2937-2026
ProNephro AKI (NGAL) Reagent Kit (100 tests)
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of ProNephro AKI (NGAL) Reagent Kit (100 tests) by Bioporto Diagnostics A S, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2937-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-18 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Bioporto Diagnostics A S |
| Distribution | n/a |
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.
Identifiers
| code_info | Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2937-2026%22
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