RecallDepth

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

Company
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
Recall Initiated
February 4, 2022
Terminated
November 6, 2024
Recall Number
Z-0814-2022
Quantity
1 unit

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.

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