FDA recall Z-0741-2022

Cytocell Ltd. · Class II · 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

Reason for recall

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

Distribution

US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.

Key facts

Status
Terminated
Initiation date
2022-01-18
Report date
2022-03-16
Termination date
2024-11-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2022