Bioporto recalls ProNephro AKI Reagent Kit (100 tests) due to potential missed kidney disease diagnoses from improper reagent use. Affected units include specific model numbers and lot numbers.
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.
Bioporto is recalling its ProNephro AKI Reagent Kit (100 tests) because improper reagent handling could lead to missed kidney disease diagnoses. This affects users who rely on the test for accurate kidney injury detection.
The reagent kit could produce inaccurate results if handled using an unvalidated process. This might cause healthcare providers to miss kidney disease cases, leading to inappropriate treatment decisions.
Healthcare providers using the ProNephro AKI Reagent Kit for kidney injury testing are most at risk. Patients relying on this test for accurate diagnosis may be affected if the kit is misused.
Check for model numbers ST101UB / 08787174 190 and lot numbers 04909125 or 04912125. The kit is sold as an IVD Acute Kidney Injury Test System.
Verify the model number and lot number to confirm if your kit is affected.
The recall is for potential missed diagnoses, not an immediate safety hazard. The risk is low as it relates to test accuracy rather than physical harm.
Check for model number ST101UB / 08787174 190 and lot numbers 04909125 or 04912125.
The recall does not specify a remedy, so contact Bioporto directly for guidance.
We’ve drafted a message you can send Bioporto to request your refund or repair — edit it as you like.
Subject: Recall Z-2937-2026 — Bioporto Bioporto Hello, I own a Bioporto that is covered by recall Z-2937-2026 from Bioporto. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
