Alinity 06P0861Recalls & reported problems
Abbott Laboratories · Alinity s Chagas Reagent Kit
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740203054), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Leak/Splash
THE CUSTOMER REPORTED THAT A TECHNICIAN WAS ATTEMPTING TO CLOSE CHAGAS POSITIVE CONTROL VIAL AND FELT DROPLETS HIT THEIR EYE AS THE CAP CLOSED. THE TECHNICIAN WHO IS A 26-YEAR-OLD MALE WAS WEARING SAFETY GOGGLES, FACE MASK, LAB COAT, AND GLOVES. DROPLETS WENT ABOVE THE RIM OF THE GOGGLES AND CONTACTED THEIR EYE. BLOOD WAS DRAWN FOR PRELIMINARY BLOOD WORK. THEY WILL BE RETURNING TO THE CLINIC IN 3 WEEKS FOR FOLLOW UP BLOOD WORK. THE TECHNICIAN IS DOING OKAY AND IS BACK AT WORK. NO FURTHER IMPACT ON PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501072 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.