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Fecal Extraction Device
INOVA DIAGNOSTICS, INC. · Model 504837 · UDI-DI 08426950846833
NXO
Prescription
10
510(k) clearances
1
Adverse events
3
Recalls
11
Facilities
Description
-100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-11-07 | Diasorin Inc. | Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Pl |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.