ABX PENTRA Enzymatic Creatinine CP ref — Class II medical device recall Z-0739-2016
Terminated recall by Horiba Instruments Inc, reported 2016-02-10, distributed in AL, AR, AZ, CA, FL, GA, ID, IL…. N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with th
| Recall number | Z-0739-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments Inc, Irvine, CA, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-02-02 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-06-07 |
| Distributed | 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 |
| Quantity | 216 |
| Model numbers | A11A01907 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0739-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.