BEUDAMED
    FDA Recall Terminated

    Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.

    Recall: Z-0470-06 · Initiated December 16, 2005

    Recall

    Recall Number
    Z-0470-06
    Event Number
    34263
    Firm
    Chembio Diagnostic System Inc
    FEI Number
    2431980
    Product Code
    GHM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2005
    Posted
    February 4, 2006
    Terminated
    June 30, 2006
    Address
    3661 Horseblock Road, Medford, NY, 11763-2215

    Description

    Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.

    Reason

    Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.

    Action

    Chembio phoned the consignees and followed up by faxing the recall letters (dated 12/15/05) & response forms on 12/22/05.

    Distribution

    Medical facilities and a few distributors located nationwide, the Dominican Republic, and West Indies (St. Vincent & Grenadine)

    Quantity

    Lot SC050305: 347 test kits, Lot SC062805: 410 test kits