Reported Mar 16, 2022 · Terminated
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML…
Cytocell Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cytocell Ltd. · 418 Cambridge Science Park, Milton Road · Cambridge, N/A · N/A
Is this the product you have?
- Del(5q) Deletion FISH Probe KitIn-Vitro Diagnostic to detect deletions in chromosome location from
- patients with AML or MDS Catalog NumberUSA-LPH024
- Lot codes and dates
- Lot Number075711 Exp
- Date2023-06-22
- UDI(01)05055844901551(17)230622(10)075 711
- Amount recalled
- 19 kits
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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