Home / Recalls / Cytocell Ltd. / Z-0741-2022

Z-0741-2022 Class II Terminated

Recalled by Cytocell Ltd. — Cambridge, N/A

Recall Details

Product Type
Devices
Report Date
March 16, 2022
Initiation Date
January 18, 2022
Termination Date
November 8, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 kits

Product 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

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 Pattern

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

Code Information

Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711

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  • Z-0353-2023 Class II — CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related m (October 27, 2022)
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