The Recall Desk

FDA (Devices) recall action 72176

Beckman Coulter Inc. recalled 2 products on 2015-10-14

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
2015-10-14
Critical
0
Units
—

Why these products were recalled

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

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

1–2 of 2

  • HighFDA (Devices)··2015-10-14

    Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.

    Product
    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-10-14

    Beckman Coulter Recalls MICroSTREP plus Panels Due to Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation, leading to false resistant results.

    Product
    MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including…
    Category
    Distribution
    0 states