CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
FDA Recall Z-0341-2023 · Posted 2022-11-30
Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodeMVU
Date Initiated2022-10-27
Date Terminated2024-12-27
Product Quantity3 units
Reason for Recall
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
Firm Action
CytoCell issued Urgent Medical Device Recall letter on 10/27/22 to end user via email. The letter states reason for recall, health risk and action to take:
Immediately examine your inventory and quarantine all product subject to recall.
Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert.
Please complete and return the enclosed response form as soon as possible.
If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.