The Recall Desk

FDA (Devices) recall action 63169

Beckman Coulter Inc. recalled 2 products on 2012-10-17

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-10-17
Critical
0
Units
—

Why these products were recalled

Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

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

1–2 of 2

  • HighFDA (Devices)··2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Th
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
    Category
    Distribution
    0 states