Z-0739-2016Class II

ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro...

Name: Z-0739-2016 ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro...
Creator: Horiba Instruments Inc
Published: 2016-01-11
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2016-01-11 / Terminated

FDA source

Horiba Instruments Inc began a recall of ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum... on 2016-01-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0739-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-02-02
Terminated: 2016-06-07
Recalling firm: Horiba Instruments Incorporated
Product: 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.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
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 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 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.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0739-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0738-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02
Z-0739-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02
Z-0740-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02
Z-0741-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02
Z-0742-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02
Z-0743-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-02

Product code CGX

K110137Class IIAbx Pentra Enzymatic Creatinine Cp, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, and Abx Pentra UrinHoriba Abx Sas / cleared 2011-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)