Device product
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Z-0341-2023
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 91119
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0341-2023
Official wording
Reason: An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
Code information: Lot Number: RD22/230/11
Distribution pattern: TX
Derived failure modes
-
Unknown
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.