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Cytocell Ltd. Recall 89602

Description: 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. Recall 89602 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0741-2022
Event ID89602
Event DescriptionDel(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Product TypeDevices
DistributionUS Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
Quantity19 kits
Recall Reasonindividual 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
Device Classification20220316
Device Code InfoLot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
Center Classification Date20220309
Recall Initiation Date20220118
Recalling FirmCytocell Ltd.
Initial Notification E-Mail
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