Cytocell Ltd. Recall 89602
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
Cytocell Ltd. Recall 89602 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0741-2022 |
| Event ID | 89602 |
| Event 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 Type | Devices |
| Distribution | US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee. |
| Quantity | 19 kits |
| Recall Reason | 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 |
| Device Classification | 20220316 |
| Device Code Info | Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711 |
| Center Classification Date | 20220309 |
| Recall Initiation Date | 20220118 |
| Recalling Firm | Cytocell Ltd. |
| Initial Notification | |
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