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U.S. Department of Health and Human Services

Class 2 Device Recall ABX PENTRA Triglycerides CPref. A11A01640

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  Class 2 Device Recall ABX PENTRA Triglycerides CPref. A11A01640 see related information
Date Initiated by Firm January 11, 2016
Date Posted February 02, 2016
Recall Status1 Terminated 3 on June 07, 2016
Recall Number Z-0742-2016
Recall Event ID 73033
510(K)Number K060854  
Product Classification Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
Product 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.
Code Information All Lots
Recalling Firm/
Manufacturer		 Horiba Instruments Inc
9755 Research Dr
Irvine CA 92618-4626
For Additional Information Contact
949-250-4811
Manufacturer 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.
FDA Determined
Cause 2		 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 documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days in order for the firm to verify the understanding of the notice. If any questions contact the local HORIBA Medical representative.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CDT and Original Applicant = HORIBA ABX
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