BEUDAMED
    FDA Recall Terminated

    Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level 1) Part No.: 465980 Lot M206192 (level 2) Part No.: 465982 Lot M206194 (level 4) Part No.: 465421 Lot M301121 (level 1) part No.: 465422 Lot M301122 (level 2) Part No.: 465424 Lot M301124 (level 4)

    Recall: Z-1155-04 · Initiated August 15, 2003

    Recall

    Recall Number
    Z-1155-04
    Event Number
    29103
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    MRR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 15, 2003
    Posted
    July 23, 2004
    Terminated
    August 30, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 Lot M206161 (level 1) Part No.: 465980 Lot M206192 (level 2) Part No.: 465982 Lot M206194 (level 4) Part No.: 465421 Lot M301121 (level 1) part No.: 465422 Lot M301122 (level 2) Part No.: 465424 Lot M301124 (level 4)

    Reason

    LDL Cholesterol component in controls are unstable.

    Quantity

    1780 all lots.