ColoSense Test Kit recall
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Why was ColoSense Test Kit recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 80-001-A2501
- Product
- ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- Recalling firm
- Geneoscopy, Inc.
- Quantity
- 10 units
- Distribution
- US Nationwide distribution in the state of Missouri.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)