BEUDAMED
    FDA Recall Terminated

    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

    Recall: Z-0029-2014 · Initiated August 9, 2013

    Recall

    Recall Number
    Z-0029-2014
    Event Number
    66105
    Firm
    OPTI Medical Systems, Inc
    FEI Number
    3004102403
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 9, 2013
    Posted
    October 18, 2013
    Terminated
    December 12, 2013
    Address
    235 Hembree Park Dr, Roswell, GA, 30076-5738

    Description

    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

    Reason

    OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

    Action

    The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or [email protected] to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: [email protected] Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.

    Distribution

    Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.

    Quantity

    361 boxes of 25 cassettes each