Recall Z-0741-2022 ยท QDI Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Cytocell Ltd.
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
| Date | Jan 18, 2022 |
| Status | Terminated |
| Reason | individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Cytocell issued Urgent Medical Recall Reference: VC/2022/001 letter on 1/18/22 to Distributors and End Users via email. 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 any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of the probe being manufactured with the fluorophores the incorrect way around. Please complete and ret |
| Quantity | 19 kits |
| Distribution | US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.