The Recall Desk

FDA (Devices) recall action 70893

Beckman Coulter, Inc. recalled 7 products on 2015-05-06

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2015-05-06
Critical
0
Units
—

Why these products were recalled

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

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

1–7 of 7

  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Drie
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  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Performance Warning

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram
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  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter Recalls MicroScan Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gr
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  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried
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  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Neg
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  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Ne
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  • ModerateFDA (Devices)··2015-05-06

    Beckman Coulter Recalls MicroScan Microbiology Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Microbiology Systems panels because a 2013 bulletin failed to mention a performance limitation for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Drie
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