CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
ColoSense Test Kit recalled by Geneoscopy
Geneoscopy is recalling ColoSense Test Kit, distributed nationwide in the US. The recall was initiated on 20 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2077-2025
- FDA event ID
- 97017
- Recalling firm
- Geneoscopy, Saint Louis, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 May 2025
- FDA classified
- 3 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 20 May 2025 | Recall initiated by company | |
| 3 Jul 2025 | Classified by FDA | +44 days |
| 9 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Where it was distributed
US Nationwide distribution in the state of Missouri.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot number 80-001-A2501
Where was it sold?
US Nationwide distribution in the state of Missouri.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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