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
Check against the official notice below — it lists the full affected range.
Cytocell Ltd. has recalled its Del(5q) Deletion FISH Probe Kit (Catalog Number USA-LPH024), a diagnostic tool used to detect deletions in chromosome 5 from patients with acute myeloid leukemia or myelodysplastic syndrome. The recall affects 19 kits distributed nationwide in Hawaii, Missouri, Pennsylvania, and Tennessee (Lot Number 075711, expiration date June 22, 2023). The kits contain components with reversed color labels—the EGR1 probe is labeled green instead of red, and the control probe is labeled red instead of green—which would cause test results to show an inverted pattern (1 green and 2 red instead of 1 red and 2 green) and produce incorrect diagnostic results.
The recalled kits have inverted fluorescent probe colors that would lead to misinterpretation of patient test results for chromosome 5q deletions. The FDA's recall notice does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee. Quantity: 19 kits Lot/code info: Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.