Horiba Instruments Inc Recall: ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intende
Horiba Instruments Inc Recall: ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intende is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Horiba Instruments Inc; Product: ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determinatio
| Recalling firm | Horiba Instruments Inc |
|---|---|
| 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20160111 |
| Recall number | Z-0740-2016 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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