The Recall Desk

FDA (Devices) recall action 73921

Beckman Coulter Inc. recalled 5 products on 2016-06-15

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2016-06-15
Critical
0
Units
—

Why these products were recalled

Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

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

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2016-06-15

    Beckman Coulter Recalls Triglyceride Assay Due to Dipyrone Interference

    Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low results.

    Product
    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-06-15

    Beckman Coulter Lactate Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lactate OSR6x93 reagent because Dipyrone may cause erroneous false low results.

    Product
    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-06-15

    Beckman Coulter Lipase Reagent Recalled for Potential False Low Results

    Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.

    Product
    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-06-15

    Beckman Coulter Uric Acid Reagent Recalled for False Low Results

    Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in assays.

    Product
    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-06-15

    Beckman Coulter Cholesterol Reagent Recalled for False Low Results

    Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.

    Product
    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
    Category
    Distribution
    1 state