BEUDAMED
    FDA Recall Terminated

    OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables 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. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.

    Recall: Z-2558-2011 · Initiated March 15, 2011

    Recall

    Recall Number
    Z-2558-2011
    Event Number
    58272
    Firm
    OPTI Medical Systems, Inc
    FEI Number
    3004102403
    Product Code
    CGZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 15, 2011
    Posted
    June 14, 2011
    Terminated
    August 8, 2011
    Address
    235 Hembree Park Dr, Roswell, GA, 30076-5738

    Description

    OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables 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. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.

    Reason

    The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.

    Action

    OPTIMedical Systems sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 15, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were notified by letter via e-mail and fax. Customers were instructed to discontinue use of the product and to return any unused product to OPTI Medical Systems, Inc. Customers outside the U.S. were instructed to destroy unused product and certify the destruction on the enclosed Recall Response Card. The Response Card was to be completed and returned to OPTI Medical Customer Service via fax. OPTI Medical Systems will replace the cassettes they have with product from another lot. Customers were instructed to contact the Technical Support Department at 1-800-490-6784 for questions relating to this notice.

    Distribution

    Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.

    Quantity

    86 boxes (25 units (per box)