Z-0741-2022 Class II Terminated
FDA device recall Z-0741-2022 was initiated by Cytocell Ltd. on January 18, 2022 and is designated Class II. 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… The recall status is terminated (terminated November 8, 2024). Affected quantity: 19 kits.
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