BEUDAMED
    FDA Recall Terminated

    Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB

    Recall: Z-0039-2017 · Initiated August 3, 2016

    Recall

    Recall Number
    Z-0039-2017
    Event Number
    74987
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CIC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 3, 2016
    Posted
    October 4, 2016
    Terminated
    May 11, 2017
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB

    Reason

    Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.

    Action

    Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB. The notification letter requested that customers discontinue use and discard the affected kit.

    Distribution

    Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.

    Quantity

    5,991 cartridges