DeviceSignal · Recall classified
Bioporto Diagnostics A/S
FDA classified a device recall on 2026-08-12 · Class II · Z-2937-2026
EventRecall classified
Effective2026-08-12
ClassificationClass II
On 2026-08-12 the FDA classified a device recall from Bioporto Diagnostics A/S as Class II. Product: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.. Recall Z-2937-2026. The firm initiated it on 2026-05-18. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2937-2026
- Classification
- Class II
- Classified on
- 2026-08-12
- Initiated on
- 2026-05-18
- Firm
- Bioporto Diagnostics A/S
- 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.
- Product
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2937-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
d8c9c17cb2bfc999d1aff70229e693d272d8dfc8929ebc9b51414c1cbf801b5d- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)