Device product
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Z-2323-2021
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 88294
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-2323-2021
Official wording
Reason: May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Code information: Lots 073004 and 072518 (Probe lot 200918-006).
Distribution pattern: US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Derived failure modes
-
Unknown
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34