TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
This recall has been terminated (originally issued February 4, 2022).
- Recall Initiated
- February 4, 2022
- Terminated
- November 6, 2024
- Recall Number
- Z-0814-2022
- Quantity
- 1 unit
- Official Source
- View on FDA website ↗
Reason for Recall
May show unexpected locus specific signals in addition to those at 14q32.
Distribution
MN
Lot / Code Info
Lot 074612
Root Cause
Under Investigation by firm
Action Taken
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.