BEUDAMED
    FDA Recall Open, Classified

    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    Recall: Z-1564-2022 · Initiated July 20, 2022

    Recall

    Recall Number
    Z-1564-2022
    Event Number
    90596
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    PPM
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 20, 2022
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    Reason

    There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

    Action

    The recalling firm issued undated letters with a reference number of FSCA#5690 via overnight mail on 7/20/2022. The letter explained the issue and instructed the customers to distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the customer may have transferred the product. They are informed they can continue to use the impacted lots of the NUCLISENS Magnetic Silica Ref 280133 listed in Table 1 except for bacterial nucleic acid detection applications, especially Legionella spp, and other applications such as 16S rDNA, 23S rDNA. The recalling firm confirms that all applications for which the negative controls are valid can be safely performed. If the customer is encountering invalid negative controls, they are to stop using it and discard the impacted lot and contact the bioMerieux representative to order lots not concerned by the issue. Based on benefit/risk analysis and to avoid product backorder, the customer is informed that for a short period of time, they may receive some of the lots listed in Table 1 of the letter with an insert that will contain the same information and actions required as previously mentioned. An Acknowledgement Form was enclosed for return to confirm receipt of the notice. The letter listed all lot numbers globally distributed, but the customers in the U.S. only received lot numbers Z012MK1MS, Z012ML1MS, Z012NB1MS, and Z013AL1MS. The U.S. customers could receive other lots listed in the letter at a later time.

    Distribution

    Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.

    Quantity

    1,301 kits