BEUDAMED
    FDA Recall Terminated

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    Recall: Z-2323-2021 · Initiated May 27, 2021

    Recall

    Recall Number
    Z-2323-2021
    Event Number
    88294
    Firm
    Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
    FEI Number
    3002646096
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 27, 2021
    Terminated
    May 9, 2022

    Description

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    Reason

    May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

    Action

    Cytocell issued Urgent Medical Device Recall Users issued via email on 5/27/21. Letter states reason for recall, heath risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that you destroy the remaining inventory. We also suggest that laboratories undertake a review any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signal at 9q34. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].

    Distribution

    US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

    Quantity

    23 units