FDA Medical Device Recalls (openFDA)
Bioporto Diagnostics A/S: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Recall number
- Z-2937-2026
- Recalling firm
- Bioporto Diagnostics A/S
- Product
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Status
- Open, Classified
- Initiated
- 2026-05-18
- Posted
- 2026-08-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 400 units
- Distribution
- 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.
- Lot, serial or model codes
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- 510(k) numbers
- ["K232761"]
- PMA numbers
- not on file
- Product code
- PIG
- Firm FEI
- 3010739981
- Firm city
- Hellerup
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28