Recall Z-0742-2016 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Horiba Instruments Inc
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
| Date | Feb 2, 2016 (initiated Jan 11, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Customer notification letters were sent on 01/11/16. Customers were provided the following instructions/actions: When performing tests that use the Tinder reaction, the blood draw should be done before treatment is given to the patient. Reagent inserts for the concerned HORIBA Medical Products have been updated and now include the following additional warning: Patients treated with N-Acetylcysteine (NAC) for Paracetamol overdose may generate a false low result. The letter request customers share the information with laboratory staff and retain the notification as part of their laboratory do |
| Quantity | 216 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060854 | ABX PENTRA 400: LIPOPROTEINS Horiba Abx, Aug 24, 2006 |