BEUDAMED
    FDA Recall Terminated

    A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

    Recall: Z-0682-2020 · Initiated December 2, 2016

    Recall

    Recall Number
    Z-0682-2020
    Event Number
    84231
    Firm
    Polymer Technology Systems
    FEI Number
    3002698769
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 2, 2016
    Terminated
    July 16, 2020
    Address
    4600 Anson Blvd, Whitestown, IN, 46075

    Description

    A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

    Reason

    A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.

    Action

    A Customer Bulletin dated November 2016 was distributed to customers.

    Distribution

    The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republic, England, Egypt, Greece, Spain, India, Indonesia, Haiti, Hong Kong, Italy, Japan, Jordan, Kenya, Lebanon, Mexico, Myanmar, Malaysia, Philippines, Pakistan, South Africa, Nigeria, Poland, Saudi Arabia, Sweden, Turkey, Singapore, Trinidad & Tobago, Slovenia, Vietnam, United Arab Emirates, Uruguay.

    Quantity

    112,648