BEUDAMED
    FDA Recall Terminated

    Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA

    Recall: Z-1562-2011 · Initiated January 26, 2010

    Recall

    Recall Number
    Z-1562-2011
    Event Number
    54551
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    JNB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2010
    Posted
    March 4, 2011
    Terminated
    March 17, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA

    Reason

    Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

    Action

    Direct accounts were notified by phone, followed by fax (domestic). Urgent Device Recall notification letters were sent out on January 26, 2010 to subsidiary along with a Bio-Rad customer form to be send to each customer. The letters identified the affected product and explained the reason for the recall. Customers were asked to examine their inventory and quarantine the affected lots listed. In addition, they are to complete and return the enclosed response form according to the instructions provided. Customers are contact their regional Bio-Rad office for Elution Buffer replacement.

    Distribution

    Worldwide Distribution -- USA, including states of MI and MN and Bio-Rad facilities in Italy, France, Czech Republic, Canada, Argentina, Panama, United Kingdom, Hong Kong, China, Canada, Singapore, India, South Korea, Brazil, and Sweden.

    Quantity

    714