Access Digoxin 33710Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590225797), received between Oct 2, 2017 and Oct 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE DIGOXIN (ACCESS DIGOXIN) RESULTS ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE PATIENT'S SAMPLE WAS ANALYZED IN TRIPLICATE AND RECOVERED WITH IMPRECISE ACCESS DIGOXIN RESULTS. THESE RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO IMPACT OR CHANGE TO PATIENT CARE OR TREATMENT IN ASSOCIATION WITH THE NON-REPRODUCIBLE ACCESS DIGOXIN RESULTS. QUALITY CONTROL (QC) WAS RECOVERING WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THE CUSTOMER REPORTED THAT QC WAS OUT OF SPECIFICATIONS THE DAY FOLLOWING THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A PLASMA SEPARATION TUBE. THE CUSTOMER WAS NOT ABLE TO PROVIDE CENTRIFUGE INFORMATION SUCH AS SPEED, TIME OR TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6908255 ↗