Recall archive / FDA device enforcement
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 — FDA record Z-0341-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Cytocell Ltd.
- Quantity
- 3 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0341-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number: RD22/230/11 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
TX
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 7, 2022
- Recall initiation date
- Oct 27, 2022
- Center classification date
- Nov 30, 2022
- Termination date
- Dec 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.