The Recall Desk

FDA (Devices) recall action 75526

Beckman Coulter Inc. recalled 2 products on 2016-11-23

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
2016-11-23
Critical
0
Units
—

Why these products were recalled

Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.

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

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-11-23

    Beckman Coulter Recalls Access Ostase Calibrators for Expiration Date Issues

    Beckman Coulter is recalling Access Ostase Calibrators because they do not meet expiration date claims within 10% criteria.

    Product
    Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoas
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2016-11-23

    Beckman Coulter Recalls Access Ostase QC for Expiration Date Issues

    Beckman Coulter is recalling Access Ostase QC kits because they do not meet expiration date claims within 10% criteria.

    Product
    Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
    Category
    Distribution
    19 states