Syva® Emit® 2000 Digoxin Assay 10445315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768000966), received between Jul 27, 2017 and Jul 27, 2017 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DIGOXIN RESULTS WERE OBTAINED FOR 2 PATIENT SAMPLES WHEN THE INTERNAL QUALITY CONTROLS (QC) RECOVERED OUT OF RANGE ON THE VIVA-E ANALYSER. THESE RESULTS WERE EXPECTED FOR THESE PATIENT AND NOT QUESTIONED BY THE PHYSICIAN(S). THE QC RANGE WAS 0.47 - 0.71 NG/ML FOR BIORAD LIQUICHECK LEVEL 1 (LOT 27711) AND 1.42 - 1.92 NG/ML BIORAD LIQUICHECK LEVEL 2 (LOT 27712). ON THE DAY OF THE EVENT, INTERNAL QC RECOVERED 0.43 NG/ML FOR LEVEL 1 AND 1.41 NG/ML FOR LEVEL 2. UPON DUPLICATION, THE INTERNAL QC RECOVERED 0.52 NG/ML FOR LEVEL 1 AND 1.46 NG/ML FOR LEVEL 2. IT IS UNKNOWN IF OTHER PATIENT SAMPLES WERE RUN WHILE THE INTERNAL QC RECOVERED OUT OF RANGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER RUNNING PATIENT SAMPLES WHILE INTERNAL QC RECOVERED OUT OF RANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746852 ↗