BEUDAMED
    FDA Recall Open, Classified

    Alinity m HBV Application Specification File (US and CE)

    Recall: Z-0883-2022 · Initiated March 4, 2022

    Recall

    Recall Number
    Z-0883-2022
    Event Number
    89757
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    MKT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 4, 2022
    Posted
    April 6, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Alinity m HBV Application Specification File (US and CE)

    Reason

    There is a potential for misquantitation high results of negative samples.

    Action

    On March 4, 2022, Abbott Molecular issued an Urgent Field Safety Notice / Field Correction Recall Notice, Urgent Field Safety Notice, and Dear Health Care Provider letter to all customers who received the Alinity m HBV Amp Kits (List Number 08N47-095 Lot Numbers 519756, 523799, 524361 and List Number 08N47-090 Lot Numbers 519755 520957, 522137, 523798, and 524059). Consignees are asked to follow the necessary actions outlined in the letter and complete and return the Customer Reply Form. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. If results are inconsistent with patient history and other diagnostics through patient monitoring, a retest of the same sample should be considered. 100% of customers are requested to return to Abbott a Customer Reply Form acknowledging receipt and understanding, and/or a request for assistance. Abbott personnel will follow up with customers by e-mailing and or follow-up visits/phone calls. The firm issued a second Urgent Field Safety Notice / Field Correction Recall notice on 01/13/2023 to consignees that received the newly identified lot numbers: (List Number 08N47-095 Lot Numbers 381583, 529391, 529687, 530273, 531598 and List Number 08N47-090 Lot Numbers 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596).

    Distribution

    US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam