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U.S. Department of Health and Human Services

Class 2 Device Recall ProNephro AKI (NGAL) Reagent Kit

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 Class 2 Device Recall ProNephro AKI (NGAL) Reagent Kitsee related information
Date Initiated by FirmMay 18, 2026
Date PostedAugust 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2937-2026
Recall Event ID 99266
510(K)NumberK232761 
Product Classification Acute kidney injury test system - Product Code PIG
ProductProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Code Information Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
FEI Number 3010739981
Recalling Firm/
Manufacturer		 Bioporto Diagnostics A/S
Tuborg Havnevej 15, St
Hellerup Denmark
For Additional Information ContactJennifer Zondermann
1-617-6942918
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA 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 in Commerce400 units
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PIG
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