BEUDAMED
    FDA Recall Terminated

    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

    Recall: Z-1144-2014 · Initiated February 4, 2014

    Recall

    Recall Number
    Z-1144-2014
    Event Number
    67436
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    OOC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 4, 2014
    Posted
    March 5, 2014
    Terminated
    November 1, 2014
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    Description

    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

    Reason

    Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.

    Action

    Focus Diagnostic initiated this recall on February 4, 2014 by sending recall notification letters to customers via email. The letter dated February 4, 2014, titled "URGENT: SAFETY NOTICE REMOVAL", informed customers of the recall (removal). The letter provided the following information: product description with code, reason for recall, the issue, the risk to health, recommendation, background, actions by customers, contact information, labeling, and response sheet.

    Distribution

    Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.

    Quantity

    2,175 kits