BEUDAMED
    FDA Recall Terminated

    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

    Recall: Z-0136-2014 · Initiated August 26, 2013

    Recall

    Recall Number
    Z-0136-2014
    Event Number
    66101
    Firm
    Bayer Healthcare Llc
    FEI Number
    3000206585
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 26, 2013
    Posted
    November 2, 2013
    Terminated
    January 14, 2014
    Address
    510 Oakmead Pkwy, Sunnyvale, CA, 94085-4022

    Description

    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

    Reason

    Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.

    Action

    Bayer Healthcare sent an Urgent Medical Device Recall letter dated August 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and quarantine any affected product. Complete the attached Recall Response Form and fax to Bayer Customer Service. Customers were instructed to use the attached letter to notify affected next level customers of the recall. For questions regarding this recall call 408-524-2255, ext 290.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.

    Quantity

    138 Kits in US (Total 2452)