ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute… recallZ-2937-2026 · Bioporto Diagnostics A/S · initiated May 18, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bioporto Diagnostics A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
A Quality Notification dated 6/3/26 was sent to consignees via email notifying them of the recall. Consignees in the US are to coordinate replacement of devices. ROW Consignees are to scrap unopened kits in accordance with local requirements and request replacements.
Recall details
- Recall number
- Z-2937-2026
- Status
- Open, Classified
- Initiated by the company
- May 18, 2026
- Posted by the FDA
- Aug 12, 2026
- Recalling firm
- Bioporto Diagnostics A/S
- Quantity
- 400 units
- Product code
- PIG
- FDA submissions
- K232761
- 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.
Product description
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Code information (models, lots, serial numbers)
Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ProNephro AKI™ (NGAL) Reagent Kit ST101UBBioporto Diagnostics A/S · Acute Kidney Injury Test System1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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