Recall Z-0814-2022 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
| Date | Feb 4, 2022 |
| Status | Terminated |
| Reason | May show unexpected locus specific signals in addition to those at 14q32. |
| Root cause | Under Investigation by firm |
| Action | Cytocell issued Urgent Medical Device Recall letter (VC/2022/005) to Distributor/End User via email on 2/4/22 . Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that you destroy the remaining inventory. We also suggest that laboratories undertake a review of the results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signals at 9q34. Please complete and return the enclosed response form as soon |
| Quantity | 1 unit |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.