Recall Z-0341-2023— Cytocell Ltd.
Class II · Terminated
Class II FDA medical device recall by Cytocell Ltd., initiated 2022-10-27, terminated 2024-12-27. Product: CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782. 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..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-10-27
- Terminated
- 2024-12-27
- Firm location
- Cambridge, United Kingdom
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.