FISH Diagnostic Probe Kit Color Labeling Error Affects Test Results
Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves diagnostic equipment with incorrect color labeling that could lead to test misinterpretation in patients with serious blood cancers. However, no illnesses or injuries have been reported, limiting the score to High rather than Severe.
Plain-English summary
Cytocell Ltd. is recalling 19 units of the Del(5q) Deletion FISH Probe Kit (Catalog Number USA-LPH024, Lot 075711) distributed nationwide to Hawaii, Missouri, Pennsylvania, and Tennessee. The kits are in-vitro diagnostic devices used to detect chromosome 5q deletions in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
The product components have been labeled with incorrect colors. The EGR1 probe is labeled green instead of red, and the control probe is labeled red instead of green. This color inversion affects test result interpretation, causing the expected positive signal pattern for a 1x deleted 5q to be 1G2R instead of the correct 1R2G, resulting in incorrect diagnostic results.
Laboratories and healthcare providers using these kits should stop using the affected lot immediately and contact Cytocell Ltd. for instructions on returning the product or obtaining corrected kits. Healthcare facilities should review any test results generated using this lot and consider retesting affected patient samples with corrected materials.
The recalled product
- Product
- 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
- Manufacturer
- Cytocell Ltd.
- Affected units
- 19
Distribution
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