BEUDAMED
    FDA Recall Terminated

    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.

    Recall: Z-1816-2015 · Initiated November 7, 2014

    Recall

    Recall Number
    Z-1816-2015
    Event Number
    70164
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 7, 2014
    Posted
    June 18, 2015
    Terminated
    May 9, 2016
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.

    Reason

    Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.

    Action

    BD sent an Urgent Field Corrective Action letter dated November 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were advised: a. Include the date recall was initiated, if it is already underway or the date your firm plans to start the recalling process. b. How do you plan to notify all the consignees affected by this recall? (press release, letter, telefax, telephone, e-mail, visit, etc.) The customer was initially contacted via a phone call and subsequently provided with a written communication. c. How do you plan to monitor the number of consignees non-responding to the recall communication? The single US customer was contacted by phone and provided the written communication. d. How do you plan to do effectiveness checks of this recall? The affected instrument will be corrected. e. Date your firm ceased further distribution of the product(s). Product was not placed on hold. This issue does not affect new customers. f. How do you plan to store the recall product? BD has not requested that instruments or reagents be returned. g. How do you plan to dispose of the recall products? BD is not requesting that customers return the instruments or reagents. If you require further assistance or clarification, please contact the BD Technical Services Department at 1-800 638-8663.

    Distribution

    Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.

    Quantity

    7 Viper LT Systems