BEUDAMED
    FDA Recall Terminated

    BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

    Recall: Z-1903-2021 · Initiated May 10, 2021

    Recall

    Recall Number
    Z-1903-2021
    Event Number
    87934
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PEN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 10, 2021
    Terminated
    December 15, 2022
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

    Reason

    Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

    Action

    On 5/10/21, BioFire distributed a "Urgent: Medical Device Correction" letter to all consignees via: E-Mail. In addition to providing consignees with a recall notification, the firm ask consignees to take the following actions: 1 Immediately examine your inventory for product identified in this recall (BCI 2 Panel Pouch Lot # 11YA20/ Kit Lot # 2039020). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. BioFire will replace the product at no charge in accordance with Biofire's Standard limited Warranty 3.Confirm the amount of pouches scrapped (if any) on the attached acknowledgement of receipt form. 4. If you may have further distributed this product, please identify any recipients and notify them at once of this product recall. 5. Please complete the accompanying Field Action acknowledgement of receipt Form and return to BioFire so that BioFire may acknowledge your receipt of this notification. 6. If you have any questions or concerns, please contact our customer support department at [email protected] or via phone at 1.800.735.6544. 7. Adverse events may also be reported to FDA's MedWatch Adverse Event Reporting program.

    Distribution

    US nationwide distribution

    Quantity

    870 kits