Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Brand
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
Lot Codes / Batch Numbers
Lot 074612
Products Sold
Lot 074612
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom is recalling TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualis due to May show unexpected locus specific signals in addition to those at 14q32.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
May show unexpected locus specific signals in addition to those at 14q32.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MN
Page updated: Jan 10, 2026