Recall Z-2829-2020 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
| Date | Jul 17, 2020 |
| Status | Terminated |
| Reason | A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green. |
| Root cause | Under Investigation by firm |
| Action | Cytocell issued Urgent Medical Device Recall Letter dated July 17,200 stating 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. Please complete and return the enclosed response form as soon as possible. We wish to sincerely apologise for any inconvenience caused as a result of this medical device recall. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com. |
| Quantity | 62 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.