Calprest

EUROSPITAL SPA · Model 9061 · UDI-DI 08028169204093

NXO Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washing solution (20x): 1x50mL vial. 5. Dilution solution (10x): 1 x20mL vial. 6. Extraction solution (2.5x): 2x50 mL vials. 7. Calibrators: 6 vials containing 1.0 ml Calprotectin at six known concentrations (6.25, 12.5, 25, 50, 100 and 200 ng/ml). 8. Control 1: 1x1.0 mL vial. 9. Control 2: 1x1.0 mL vial. 10. Microtiter plate cover: 1 piece.

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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Data 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.