BEUDAMED
    FDA Recall Terminated

    K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.

    Recall: Z-0850-06 · Initiated April 11, 2006

    Recall

    Recall Number
    Z-0850-06
    Event Number
    35169
    Firm
    Kamiya Biomedical Company
    FEI Number
    2084025
    Product Code
    DCK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 11, 2006
    Posted
    May 6, 2006
    Terminated
    May 16, 2006
    Address
    12779 Gateway Dr., Seattle, WA, 98168

    Description

    K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.

    Reason

    Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent

    Action

    Customers were contacted via telephone on 4/11/06. Customers were asked to confirm the number of kits in their possession and then open the kits to verify which vials they received in their kits. If the kits contained both vials, then the customer was instructed to keep the kit. If the kits contained the wrong vials, then they were requested to return the kits. This was followed by a letter dated 4/17/06. The letter confirmed the telephone call and asked the customer to sign and return the letter to acknoweldge receipt of the letter.

    Distribution

    Kits were distributed to laboratories nationwide. One foreign account in Singapore.

    Quantity

    185 kits