Recall archive / FDA device enforcement
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA seque... — FDA record Z-0814-2022
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 Feb 4, 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
- TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
- Reason
- May show unexpected locus specific signals in addition to those at 14q32.
- Classification
- Class III
- Recalling firm
- Cytocell Ltd.
- Quantity
- 1 unit
- Agency-reported status
- Terminated
- Source record identifier
- Z-0814-2022
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 074612 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MN
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
- Mar 30, 2022
- Recall initiation date
- Feb 4, 2022
- Center classification date
- Mar 21, 2022
- Termination date
- Nov 6, 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.