BEUDAMED
    FDA Recall Open, Classified

    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    Recall: Z-1596-2023 · Initiated April 5, 2023

    Recall

    Recall Number
    Z-1596-2023
    Event Number
    92056
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    KQO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 5, 2023
    Posted
    May 17, 2023
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500

    Description

    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    Reason

    Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.

    Action

    Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/05/2023 by mail. The notice explained the issue and the hazard and requested the following actions be taken: "Examine your specimen settings to determine if the optional 'Sperm Present' and 'Previous Sample Had Sperm' flags are enabled. If disabled, no further action is needed by your laboratory. If enabled, follow the actions below If the presence of sperm is identified: Review the previous specimen for the presence of sperm. Follow recommendations under Previous Sample Had Sperm in the iQ200 Series Instructions For Use (IFU) 300-4320CE and 300-4321EE and DxU 850m and DxU 840m Iris IFU (C49320AB) in Chapter 6, Data Review, Flags, Previous Sample Had Sperm, Recommendations. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter."

    Distribution

    Worldwide Distribution

    Quantity

    1068 units