FDA recall Z-2323-2021

Cytocell Ltd. · Class II · device

Product

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Reason for recall

May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

Distribution

US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

Key facts

Status
Terminated
Initiation date
2021-05-27
Report date
2021-08-25
Termination date
2022-05-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2021