ABBOTT 8L34-68Recalls & reported problems
Abbott Laboratories · ABBOTT ESA Chagas Assay 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 00380740089535), received between May 30, 2017 and May 30, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (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.
Most reported problems
Device problems
- High Test Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2017High Test Results; High Test Results
THE CUSTOMER REPORTED A BLOOD DONOR WHO TESTED REACTIVE FOR PRISM ANTI-T.CRUZI AND WAS ESA CHAGAS POSITIVE. THE SAMPLE WAS SENT FOR FOLLOW-UP TESTING BY THE CDC FOR T.CRUZI AB EIA AND T.CRUZI AB IB (TESA) WHICH WERE BOTH NEGATIVE. THERE WAS NO REPORTED IMPACT TO DONOR MANAGEMENT. THERE WAS NO ADDITIONAL DONOR INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6598065 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.