BEUDAMED
    FDA Recall Terminated

    PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.

    Recall: Z-2641-2010 · Initiated July 6, 2010

    Recall

    Recall Number
    Z-2641-2010
    Event Number
    56188
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 6, 2010
    Posted
    September 30, 2010
    Terminated
    May 11, 2011
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.

    Reason

    The test strips appear to under-recover Cholesterol, HDL and glucose.

    Action

    Distributors and direct customers were notified by letter on July 2, 2010. They were told to discontinue use and dispose of the affected lot of test strips. The firm also asked customers to complete an acknowledgement and confirmation document .

    Distribution

    US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.

    Quantity

    5805