ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
FDA Recall Z-0740-2016 · Posted 2016-02-02
Advertisement
Recalling FirmHoriba Instruments Inc
Recall StatusTerminated
Product CodeCFR
Date Initiated2016-01-11
Date Terminated2016-06-07
Product Quantity216
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.
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.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement