Device product
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
Z-0741-2022
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 89602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 kits
- Official record key
device-enforcement:Z-0741-2022
Official wording
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
Code information: Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
Distribution pattern: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
Derived failure modes
-
Unknown
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