ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is… recallZ-0740-2016 · Horiba Instruments Inc · initiated Jan 11, 2016
Class II Terminated All recalls posted in February 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Horiba Instruments Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0740-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 11, 2016
- Posted by the FDA
- Feb 2, 2016
- Recalling firm
- Horiba Instruments Inc
- Quantity
- 216
- Product code
- CFR
- FDA submissions
- K052007
- 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.
Product description
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.
Code information (models, lots, serial numbers)
All Lots
Other devices under the same FDA submission
1 device cleared under K052007 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ABX PENTRA ETCHING CP 1220001769Horiba Abx Sas · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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