FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
- Recall number
- Z-0814-2022
- Recalling firm
- Cytocell Ltd.
- Product
- TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
- Status
- Terminated
- Initiated
- 2022-02-04
- Posted
- not on file
- Terminated
- 2024-11-06
- Reason
- May show unexpected locus specific signals in addition to those at 14q32.
- Root cause
- Under Investigation by firm
- Action
- Cytocell issued Urgent Medical Device Recall letter (VC/2022/005) to Distributor/End User via email on 2/4/22 . 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 you destroy the remaining inventory. We also suggest that laboratories undertake a review of the results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signals at 9q34. 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
- 1 unit
- Distribution
- MN
- Lot, serial or model codes
- Lot 074612
- 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