Device product
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Z-2134-2021
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 88138
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-2134-2021
Official wording
Reason: The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
Code information: Lot Numbers: 071399 072985
Distribution pattern: Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.
Derived failure modes
-
Unknown
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.