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Terminated

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

FDA Recall Z-0814-2022 · Posted None

Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodeMVU
Date Initiated2022-02-04
Date Terminated2024-11-06
Product Quantity1 unit

Reason for Recall

May show unexpected locus specific signals in addition to those at 14q32.

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

MN

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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