FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
- Recall number
- Z-0341-2023
- Recalling firm
- Cytocell Ltd.
- Product
- CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
- Status
- Terminated
- Initiated
- 2022-10-27
- Posted
- 2022-11-30
- Terminated
- 2024-12-27
- 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
- Lot, serial or model codes
- Lot Number: RD22/230/11
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 3002646096
- Firm city
- Cambridge
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28