CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report

ABX Pentra Glucose PAP CP recalled by Horiba Instruments

Horiba Instruments is recalling ABX Pentra Glucose PAP CP, distributed in 29 states. The recall was initiated on 11 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalled216

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0740-2016
FDA event ID: 73033
Recalling firm: Horiba Instruments, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2016
FDA classified: 2 Feb 2016
Reported: 10 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

11 Jan 2016	Recall initiated by company
2 Feb 2016	Classified by FDA	+22 days
10 Feb 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Alabama Arkansas Arizona California Florida Georgia Idaho Illinois Kansas Kentucky Maryland Michigan Minnesota Mississippi Montana North Carolina Nebraska New Mexico New York Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lots

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 73033

Reported	Class	Recall	Company	Reason	Where
10 Feb 2016	CLASS II	ABX Pentra Triglycerides CP recalled by Horiba Instruments	Horiba Instruments	Potency & Assay	29 states
10 Feb 2016	CLASS II	ABX Pentra Uric Acid CP recalled by Horiba Instruments	Horiba Instruments	Potency & Assay	29 states
10 Feb 2016	CLASS II	ABX Pentra Lactic Acid CP recalled by Horiba Instruments	Horiba Instruments	Other	29 states
10 Feb 2016	CLASS II	The ABX Pentra Cholesterol CP recalled by Horiba Instruments	Horiba Instruments	Potency & Assay	29 states
10 Feb 2016	CLASS II	ABX Pentra Enzymatic Creatinine CP recalled by Horiba Instruments	Horiba Instruments	Other	29 states

More recalls from Horiba Instruments

All 28

Reported	Class	Recall	Company	Reason	Where
10 Jul 2024Device	CLASS II	Horiba custom configured fluorescence instrument recalled	Horiba Instruments	Foreign Material	Nationwide
16 Oct 2019Device	CLASS II	Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400 recalled	Horiba Instruments	Other	40 states
4 Jul 2018Device	CLASS II	ABX Pentra Micro Albumin 2 CP, Serum/Plasma recalled	Horiba Instruments	Other	Nationwide
7 Feb 2018Device	CLASS II	Reagent Cup, B1037307, Sap 1221037307 for use recalled	Horiba Instruments	Device Malfunction	Nationwide
7 Feb 2018Device	CLASS II	Reagent Cup, B1034626, Sap 1221034626 for use recalled	Horiba Instruments	Device Malfunction	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

All 468

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	The MiniMed Go app for iOS or MiniMed Go app recalled	Medtronic MiniMed	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide