Bioporto ProNephro AKI Reagent Kit Recall: Risk of Missed Kidney Disease Diagnosis
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.
Lower-risk recall
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.
What happened, in plain English
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. Read more at govinfonow.com/recall/459730-bioporto-pronephro-aki-reagent-kit-recall-risk-of-missed-kidney.
Source Summary by GovInfoNow · govinfonow.com/recall/459730-bioporto-pronephro-aki-reagent-kit-recall-risk-of-missed-kidney · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2937-2026
Cite this page
“Bioporto ProNephro AKI Reagent Kit Recall: Risk of Missed Kidney Disease Diagnosis.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459730-bioporto-pronephro-aki-reagent-kit-recall-risk-of-missed-kidney. Based on FDA recall #Z-2937-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2937-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Bioporto- Product
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System- Category
Medical device
What to do — step by step
Check Kit Details
Verify the model number and lot number to confirm if your kit is affected.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-2937-2026 (May 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2937-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.