BEUDAMED
    FDA Recall Terminated

    VerifyNow P2Y12 Assay Device Kit, Part Number 85054

    Recall: Z-0228-2007 · Initiated September 5, 2006

    Recall

    Recall Number
    Z-0228-2007
    Event Number
    36707
    Firm
    Accumetrics Inc
    FEI Number
    3001376288
    Product Code
    JOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2006
    Posted
    December 6, 2006
    Terminated
    March 26, 2012
    Address
    3985 B Sorrento Valley Blvd, San Diego, CA, 92121

    Description

    VerifyNow P2Y12 Assay Device Kit, Part Number 85054

    Reason

    The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.

    Action

    The 333 consignees were notified by regular mail or by E-mail on 9/5/2006 -- 9/13/2006. There were four versions of the notification letter tailored to (1) domestic customers; (2) domestic distributors; (3) international customers; and (4) international distributors. Each notification was accompanied by a 'fax back' form which customers were asked to sign and return to Accumetrics as an acknowledgement they received the notification letter. The notification letter instructs consignees that test results with the VerifyNow P2Y12 Assay and all VerifyNow assays should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Caution is advised when testing patients outside the ranges documented in the package insert.

    Distribution

    Worldwide Distribution- USA, and countries of Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, & United Kingdom

    Quantity

    333