Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to recall: Labeling Error
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number…
Why was Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
- Product
- Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number…
- Recalling firm
- Cytocell Ltd.
- Quantity
- 19 kits
- Distribution
- US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
- Recall date
- March 16, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)