Horiba ABX PENTRA Glucose Reagent Recalled for NAC Interference
Horiba Instruments Inc is recalling ABX PENTRA Glucose reagents because N-acetylcysteine in patient blood can cause falsely low glucose results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the use of the product may cause temporary or medically reversible health consequences, such as inaccurate diagnostic results.
Plain-English summary
Horiba Instruments Inc is recalling 216 units of ABX PENTRA Glucose PAP CP reagent (ref. A11A01668). This product is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma, and urine using the glucose oxidase method by colorimetry.
The recall is due to a potential for inaccurate test results. N-acetylcysteine (NAC), which is present in the blood of patients treated for paracetamol overdose, can interfere with the Trinder reaction used by the reagent. This interference can produce falsely low glucose results.
The affected units were distributed in the United States to the following states: 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, and TN. There was no foreign distribution. All lots are affected. Consumers and healthcare facilities should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Horiba Instruments Inc
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 6 recalled by Horiba Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Horiba Instruments Inc
See all →- HighHoriba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers
FDA (Devices) · 2016-05-04
- HighHoriba Recalls ABX Pentra 400 Analyzers Due to Malfunctions
FDA (Devices) · 2016-05-04
- HighHoriba ABX PENTRA Lactic Acid Reagent Recalled for Interference
FDA (Devices) · 2016-02-10
- ModerateHoriba ABX PENTRA Cholesterol CP Reagent Recalled for Interference
FDA (Devices) · 2016-02-10
- ModerateHoriba Instruments Recalls ABX PENTRA Enzymatic Creatinine Reagent Due to Interference
FDA (Devices) · 2016-02-10
Same hazard · inaccurate diagnostic results
See all →- Highi-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
FDA (Devices) · 2026-05-06
- HighSiemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results
FDA (Devices) · 2020-09-23
- ModerateTosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighSiemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift
FDA (Devices) · 2020-02-26