FDAFDA · Food and drugs·Recall number Z-0741-2022
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
Published March 16, 2022 · Recall initiated: January 18, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Cytocell Ltd.
- Distributor
- US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
- Lot
- Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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