BEUDAMED
    FDA Recall Terminated

    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is 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.

    Recall: Z-0846-2014 · Initiated January 10, 2014

    Recall

    Recall Number
    Z-0846-2014
    Event Number
    67213
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    January 10, 2014
    Posted
    January 28, 2014
    Terminated
    October 15, 2014
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    Description

    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is 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.

    Reason

    Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.

    Action

    Focus Diagnostics sent an Urgent Safety Notice Correction letter dated January 10, 2014, via email and a hard copy letter by mail. The letter informed customers of the correction, product description with codes, product intended use, issue, risk to health, background, recommendation, actions by customers, and contact information. Customers were instructed to check their inventory for the affected product, if customers detect any positive RSV results, confirm the positive result by an alternate method. Customers were asked to complete the "URGENT: SAFETY NOTICE Acknowledgement and Receipt Form Response Required". Customers with questions were instructed to contact their Technical Services department at 800-838-4548, select option 3. For questions regarding this recall call 714-220-1900.

    Distribution

    Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .

    Quantity

    1,052 kits