The Recall Desk

FDA (Devices) recall action 73033

Horiba Instruments Inc recalled 6 products on 2016-02-10

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2016-02-10
Critical
0
Units
1,296

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2016-02-10

    Horiba ABX PENTRA Uric Acid CP Recalled for Interference

    Horiba Instruments Inc is recalling ABX PENTRA Uric Acid CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder
    Category
    Distribution
    29 states
  • HighFDA (Devices)··2016-02-10

    Horiba ABX PENTRA Lactic Acid Reagent Recalled for Interference

    Horiba Instruments Inc. is recalling ABX PENTRA Lactic Acid CP reagents because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (ab
    Category
    Distribution
    29 states
  • ModerateFDA (Devices)··2016-02-10

    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.

    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.
    Category
    Distribution
    29 states
  • ModerateFDA (Devices)··2016-02-10

    Horiba Instruments Recalls ABX PENTRA Triglycerides Assay Due to Interference

    Horiba Instruments Inc is recalling ABX PENTRA Triglycerides CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with a
    Category
    Distribution
    29 states
  • ModerateFDA (Devices)··2016-02-10

    Horiba ABX PENTRA Cholesterol CP Reagent Recalled for Interference

    Horiba Instruments Inc is recalling 216 units of ABX PENTRA Cholesterol CP reagent because N-acetylcysteine can cause falsely low results.

    Product
    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a c
    Category
    Distribution
    29 states
  • ModerateFDA (Devices)··2016-02-10

    Horiba Instruments Recalls ABX PENTRA Enzymatic Creatinine Reagent Due to Interference

    Horiba Instruments Inc. is recalling ABX PENTRA Enzymatic Creatinine CP reagent because N-acetylcysteine in patient blood can cause falsely low results.

    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.
    Category
    Distribution
    29 states