Geneoscopy, Inc. has recalled 10 units of the ColoSense Test Kit (Part No. 80-001) because a specific lot contains a control component that is out of range. This defect causes the test plates to fail during laboratory use, which prevents the test from functioning as intended. The recall affects lot number 80-001-A2501, which was distributed to facilities in Missouri.
The faulty control component causes laboratory plate failures, which makes the test unusable and could potentially delay important diagnostic results for patients.
Firm initiated voluntary recall via letter notification.
Component of ColoSense test
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Sources: FDA iRES · Raw API Response
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