BEUDAMED
    FDA Recall Terminated

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    Recall: Z-2292-2019 · Initiated June 29, 2018

    Recall

    Recall Number
    Z-2292-2019
    Event Number
    81420
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 29, 2018
    Posted
    August 19, 2019
    Terminated
    April 28, 2021
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    Reason

    An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.

    Action

    On July 10, 2018, the firm sent an "URGENT: FIELD SAFETY NOTICE" to customers via email (with a follow-up telephone call) informing them that they may have received an affected barcode scanner. The Notice explained that when the potentially affected barcode scanner is used on multiple ARIES cassettes at the same time, the system may prepopulate the Sample ID field with a previously stored sample ID. This field will be overwritten by scanning or manually entering a sample, but in the event the ARIES cassette is not scanned, the prepopulated field may cause the incorrect association of sample identification to occur. The firm has conducted internal investigation that have shown that the firmware version on hand-held barcode scanner contained the incorrect version of firmware approved for use with the ARIES Systems. Given that the ARIES System barcode scanner (CN-0321-01 /JDK-2330 Rev B) has the potential to contribute to an incorrect result by creating the possibility that a Patient/Sample ID may be assigned to the wrong cassette, we are voluntarily initiating a recall to ensure no additional handheld scanners have this discrepant firmware. There have not been any adverse events associated with the use of the ARIES System barcode scanners at this time. To confirm whether or not the customer's particular barcode scanner is affected, the firm is advising its customer to verify the firmware version of the handheld barcode scanner by following the attached instructions ("Confirming the Firmware Version on the ARIES Hand-Held Barcode Scanner") . An affected unit will include the labeling JDK-2330 Rev B on the underside of the scanner AND will have firmware version PAACES00-002-R03 or CAACES00-002-R03. Please contact Technical Support if you identify a discrepant barcode scanner model. Correct Model and Firmware (below) Model/Rev. Firmware Version JDK-2330 Rev B. PAACES00-001-R03 CAACES00-001-R03 If the in

    Distribution

    Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

    Quantity

    153 (140 U.S. and 13 O.U.S.)