FDA Device recall Z-0341-2023
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
- FDA Device
- Class II
- terminated
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 by Cytocell, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0341-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-27 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | TX |
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.
Identifiers
| code_info | Lot Number: RD22/230/11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0341-2023%22
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