Z-0341-2023 Class II Terminated
FDA device recall Z-0341-2023 was initiated by Cytocell Ltd. on October 27, 2022 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 27, 2024). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- October 27, 2022
- Termination Date
- December 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Reason for Recall
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.
Distribution Pattern
TX
Code Information
Lot Number: RD22/230/11