Cytocell Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0741-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 18, 2022

Date Posted: March 16, 2022

Recall Number: Z-0741-2022

Event ID: 89602

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

Status: Terminated

Product Quantity: 19 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated