FDAJanuary 11, 2016device
ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.
What to do
FDA enforcement status: Terminated
Brands named
horiba instrumentshoriba
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-1592026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-1492026-03-02
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