Bioporto Diagnostics A/S recall: ProNephro AKI
Bioporto Diagnostics A/S is recalling ProNephro AKI – 400 units. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on May 18, 2026. Distributed 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..
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | ProNephro AKI |
| Brand | Bioporto Diagnostics A/S |
| Type | Medical devices |
| Classification | Class II |
| Recall date | May 18, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | 400 units |
| Recall ID | 99266 |
Recalled products
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- FDA recall number
- Z-2937-2026
- Codes, lots and dates
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- Quantity
- 400 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99266
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Hellerup, Denmark
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99266, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Bioporto Diagnostics A/S ProNephro AKI recalled?
Yes. Bioporto Diagnostics A/S recalled it on May 18, 2026; FDA published it August 19, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
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..
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.