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Recall Observatory FDA recall evidence

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

Z-0814-2022

February 04, 2022

Class III

Product summary

Firm
Cytocell Ltd.
Event
Event 89669
Status
Terminated
Classification
Class III
Quantity
1 unit
Official record key
device-enforcement:Z-0814-2022

Official wording

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

Code information: Lot 074612

Distribution pattern: MN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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