BEUDAMED
    FDA Recall Terminated

    Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing

    Recall: Z-0846-2012 · Initiated September 8, 2011

    Recall

    Recall Number
    Z-0846-2012
    Event Number
    60750
    Firm
    Lin-Zhi International Inc
    FEI Number
    3003610499
    Product Code
    DIS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 8, 2011
    Posted
    January 24, 2012
    Terminated
    January 25, 2012
    Address
    670 Almanor Ave, Sunnyvale, CA, 94085-3513

    Description

    Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing

    Reason

    Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.

    Action

    Lin-Zhi sent a letter via e-mail dated September 8, 2011 to customers with information regarding the recall. The e-mail identified the product description, lot number, description of nonconformity and corrective actions to be taken. Each customer and distributor was then contacted by regulatory affairs personnel by phone on September 9, 2011 or September 12, 2011. Customers and distributors were contacted to determined whether they wanted a replacement of the affected product. Customers that wished for replacements of the affected product was asked to correctly dispose of the product with the lot numbers listed. For questions or concern call 408-732-3856.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.

    Quantity

    72 small kits, 12 large kits.