FDA recall Z-0814-2022

Cytocell Ltd. · Class III · device

Product

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

Reason for recall

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

Distribution

MN

Key facts

Status
Terminated
Initiation date
2022-02-04
Report date
2022-03-30
Termination date
2024-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2022