Z-0738-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2016
- Initiation Date
- January 11, 2016
- Termination Date
- June 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216
Product Description
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.
Distribution Pattern
U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
Code Information
All Lots