FDA Device recall Z-0739-2016
ABX PENTRA Enzymatic Creatinine CP ref
- FDA Device
- Class II
- terminated
- Published 2016-02-10
On 2016-02-10 the FDA classified a Class II recall of ABX PENTRA Enzymatic Creatinine CP ref by Horiba Instruments, citing 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 aminoanti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0739-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-02-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Horiba Instruments |
| Distribution | AL, AR, AZ, CA, FL, GA, ID, IL, KS, KY, MD, MI, MN, MS, MT, NC, NE, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV |
Product
ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
Reason
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0739-2016%22
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