Bioporto ProNephro AKI Reagent Kit Recalled for Non-Validated Rework Process
Bioporto Diagnostics is recalling ProNephro AKI Reagent Kits because a non-validated rework process could lead to missed diagnoses of renal disease.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for missed diagnoses of renal disease due to a non-validated rework process.
Plain-English summary
Bioporto Diagnostics A/S is recalling 400 units of the ProNephro AKI (NGAL) Reagent Kit (100 tests), an IVD Acute Kidney Injury Test System. The affected lots are 04909125 and 04912125, with model number ST101UB / 08787174 190 and GTIN code 5711435000156.
The recall was initiated because a non-validated rework process was used for the assay reagents. This process could lead to a missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
The affected product was distributed worldwide, including the United States, the European Union, Chile, and Hong Kong. No affected product was distributed to Canada, though Health Canada was notified because the product is registered there. Users should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Manufacturer
- Bioporto Diagnostics A/S
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model number: ST101UB / 08787174 190
- GTIN code: 5711435000156
- Lot-number: 04909125 and 04912125.
Distribution
Distribution scope not specified by the agency.
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