CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
FDA device recall Z-0341-2023 · posted 2022-11-30 · Terminated
Recall details
- Recalling firm
- Cytocell Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 3 units
- Distribution
- TX
- Date initiated
- 2022-10-27
- Date posted
- 2022-11-30
- Date terminated
- 2024-12-27
- Location
- Cambridge, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.