VIDAS® NEPHROCHECK® 421172-01Recalls & reported problems
Biomerieux SA · VIDAS NEPHROCHECK 60 TESTS is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the risk assessment for moderate or severe acute kidney injury · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026616038), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2024Low Test Results; Low Test Results
PRODUCT DESCRIPTION. VIDAS® NEPHROCHECK® IS AN AUTOMATED TEST FOR USE ON THE VIDAS® 3 INSTRUMENT FOR THE IMMUNOENZYMATIC QUANTITATIVE DETERMINATION OF TIMP-2 (TISSUE INHIBITOR OF METALLOPROTEINASE-2) AND IGFBP-7 (INSULIN-LIKE GROWTH FACTOR-BINDING PROTEIN 7) PROTEINS IN HUMAN URINE USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY) FOR CALCULATION OF THE AKIRISK¿ SCORE. THE VIDAS® NEPHROCHECK® ASSAY IS INTENDED TO BE USED IN CONJUNCTION WITH CLINICAL EVALUATION IN PATIENTS WHO CURRENTLY HAVE OR HAVE HAD WITHIN THE PAST 24 HOURS ACUTE CARDIOVASCULAR AND OR RESPIRATORY COMPROMISE AND ARE ICU PATIENTS AS AN AID IN THE RISK ASSESSMENT FOR MODERATE OR SEVERE ACUTE KIDNEY INJURY (AKI) WITHIN 12 HOURS OF PATIENT ASSESSMENT. THE VIDAS® NEPHROCHECK® TEST IS INTENDED TO BE USED IN PATIENTS 21 YEARS OF AGE OR OLDER. ISSUE DESCRIPTION . ON 29-MAR-2024, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING AN OUT-OF-RANGE RESULTS WHEN TESTING AN EXTERNAL QUALITY CONTROL WITH VIDAS NEPHROCHECK 60 T - US (REF. 421172-01, LOT: 1010057250, EXPIRY DATE: 24-SEP-2024). THE CUSTOMER TESTED THE EXTERNAL QUALITY CONTROL LQC FROM CLINIQA (LOT 2312117) WITH VIDAS NEPHROCHECK 60 T - US
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19097501 ↗
Other Acute kidney injury test system devices
- ProNephro AKI™ (NGAL) Reagent Kit ST101UBBioporto Diagnostics A/S · Acute Kidney Injury Test System1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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