The Recall Desk

FDA (Devices) recall action 72779

Beckman Coulter Inc. recalled 5 products on 2016-01-06

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
2016-01-06
Critical
0
Units
—

Why these products were recalled

Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.

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

1–5 of 5

  • SevereFDA (Devices)··2016-01-06

    Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
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    0 states
  • HighFDA (Devices)··2016-01-06

    Beckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo and Breakpoint Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidio
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    Distribution
    0 states
  • HighFDA (Devices)··2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negative Results

    Beckman Coulter is recalling MicroScan Pos Combo panels that may produce falsely negative Voges-Proskauer results for Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidio
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    Distribution
    0 states
  • HighFDA (Devices)··2016-01-06

    Beckman Coulter MicroScan Pos Combo Panel Recall for False Negatives

    Beckman Coulter is recalling MicroScan Pos Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.

    Product
    MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidio
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    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-06

    Beckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panels because they may produce falsely negative results for Staphylococcus aureus quality control tests.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
    Category
    Distribution
    0 states