Recall Z-0341-2023 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
| Date | Nov 30, 2022 (initiated Oct 27, 2022) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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 vigilance@ogt.com. |
| Quantity | 3 units |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.