TCL1 Breakapart Probe — Class III medical device recall Z-0814-2022
Terminated recall by Cytocell Ltd., reported 2022-03-30, distributed in MN. May show unexpected locus specific signals in addition to those at 14q32.
| Recall number | Z-0814-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2022-02-04 |
| Classified | 2022-03-21 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2024-11-06 |
| Distributed | MN |
| Quantity | 1 units |
| Lot numbers | 074612 |
| Model numbers | LPH046-A |
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 for recall
May show unexpected locus specific signals in addition to those at 14q32.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0814-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.