The ABX PENTRA Cholesterol CP ref — Class II medical device recall Z-0738-2016
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-0738-2016 |
|---|---|
| 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 | A11A01634 |
Product
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
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-0738-2016. 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.