BEUDAMED
    FDA Recall Terminated

    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

    Recall: Z-0914-2020 · Initiated October 28, 2019

    Recall

    Recall Number
    Z-0914-2020
    Event Number
    84577
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    LKM
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    October 28, 2019
    Terminated
    April 1, 2026
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

    Reason

    Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

    Action

    An Urgent Medical Device Recall letter was sent during the week of 10/28/2019 to the affected customers via mail and e-mail. The notice stated the misidentification issue as follows: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics)." The following actions were provided to reduce the potential for this issue until a software update is available: - Follow good laboratory practice (GLP) and ensure that a unique identification system is in place. - Ensure that specimens are labeled with a unique Specimen ID and manual orders utilize a unique Specimen ID. - Do not reuse barcode number that identify different specimens. If barcode numbers must be reused, ensure results have been released from the LIS and the instrument Work List has been cleared. - Clear all manual Orders immediately after results are released, even if barcodes are used for subsequent runs (see iQ200 or iChemVELOCITY IFU, Chaper 7, Manual Orders).

    Distribution

    Worldwide distributions.

    Quantity

    6601 devices