ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
USProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Recalling Firm: Bioporto Diagnostics A/S
Reason for Recall / Hazard
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.
Product Description & Identification
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Additional Source Details
| Field | Value |
|---|---|
| City | Hellerup |
| Event id | 99266 |
| Address 1 | Tuborg Havnevej 15, St |
| Code info | Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Devices |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260518 |
| Initial firm notification | |
| Center classification date | 20260812 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmBioporto Diagnostics A/S
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Bioporto Diagnostics A/S - ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. Check if your household is affected: https://therecallfile.com/recalls/pronephro-aki-ngal-reagent-kit-100-tests-ivd-acute-kidney-injury-test/FDA-Z-2937-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Featured on Product Hunt
Help support our public safety mission and check out our community launch.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKCobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
Cobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of rev...
UKNGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
NGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
The NGPod handheld device and NGPod sensor, used to test pH to aid the placement of nasogastric tubes, is being withdrawn from the UK market. The manufacturer has ceased trading in the UK. Users shoul...
UKField Safety Notices: 17 to 21 August 2026
Field Safety Notices: 17 to 21 August 2026
List of Field Safety Notices from 17 to 21 August 2026....