ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S · The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inapp…
Open FDA's page for this record- Cfres ID
- 221169
- Product res number
- Z-2937-2026
- Event date initiated
- 2026-05-18
- Event date posted
- 2026-08-12
- Recall status
- Open, Classified
- Res event number
- 99266
- Product code
- PIG
- Product description
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Code info
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- Firm FEI number
- 3010739981
- Recalling firm
- Bioporto Diagnostics A/S
- Address 1
- Tuborg Havnevej 15, St 15 tuborg havnevej
- Address 2
- St
- City
- Hellerup
- Country
- Denmark
- Additional info contact
- Jennifer Zondermann 1-617-6942918
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 400 units
- Reason for 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.
- Action
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.
- Distribution pattern
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.
- K numbers
- K232761
- Harmonized identifiers (openFDA)
- Device name
- Acute Kidney Injury Test System
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1220
- Device class
- 2
- K number
- K153165, K171482, K210793, K232761, DEN130031
- Registration number
- 8020790, 3010739981
- FEI number
- 1000611339, 3010739981