Z-0739-2016 Class II Terminated
FDA device recall Z-0739-2016 was initiated by Horiba Instruments Inc on January 11, 2016 and is designated Class II. 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, an… The recall status is terminated (terminated June 7, 2016). Affected quantity: 216.
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
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.
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