FDA-Device2022-03-16Class II
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
Cytocell Ltd.
Hazard
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
Sold states
US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
Affected count
19 kits
Manufactured in
418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2022Don't want to check this manually?
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