BEUDAMED
    FDA Recall Open, Classified

    cobas infinity central lab, Material Number 07154003001

    Recall: Z-0952-2023 · Initiated December 12, 2022

    Recall

    Recall Number
    Z-0952-2023
    Event Number
    91299
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JQP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 12, 2022
    Posted
    January 12, 2023
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    cobas infinity central lab, Material Number 07154003001

    Reason

    A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

    Action

    On December 12, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were informed of the product issue. A Roche Diagnostics representative will contact you in the near future to assess your cobas infinity configuration and to determine if it meets all pre-conditions. If so, your Roche representative will work with you to implement a workaround immediately in addition to working with you to apply a more permanent solution via a software patch once available. Customers should consult with a physician or pathologist at your facility to determine clinical implications specific to your patients. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about this recall.

    Distribution

    Domestic distribution nationwide. Foreign distribution pending.

    Quantity

    224 US; 2,797 worldwide