FDA Device recall Z-0814-2022
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome C…
- FDA Device
- Class III
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class III recall of TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome C… by Cytocell, citing may show unexpected locus specific signals in addition to those at 14q32.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0814-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-02-04 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cytocell |
| Distribution | MN |
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.
Identifiers
| code_info | Lot 074612 |
|---|
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-0814-2022%22
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