FDAMay 20, 2025device
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
What to do
FDA enforcement status: Ongoing
Brands named
geneoscopy
Recall history
No related federal recalls on record for this brand yet.
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