BEUDAMED
    FDA Recall Terminated

    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

    Recall: Z-2631-2017 · Initiated July 21, 2009

    Recall

    Recall Number
    Z-2631-2017
    Event Number
    77451
    Firm
    Medtest Holdings, Inc.
    FEI Number
    1827821
    Product Code
    DCK
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 21, 2009
    Posted
    June 26, 2017
    Terminated
    July 24, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

    Reason

    Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.

    Action

    Technical Bulletin sent notification on July 21, 2009, to affected consignees via e-mail, fax and US Mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. Customers with questions were instructed to contact Pointe Scientific's Technical Service Department at 1-800-757-5313. For questions regarding this recall call 800-757-5313.

    Distribution

    Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE

    Quantity

    323 vials