Access Toxo IgM II 34470Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590624804), received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “False Positive Result” (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. 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.

• InjuryOct 1, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED OBTAINING A REPRODUCIBLE REACTIVE TOXOPLASMOSIS GONDII IGM (ACCESS TOXO IGM) RESULT FOR ONE PREGNANT FEMALE (1) PATIENT ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM TWO (2) ADDITIONAL TIMES USING NEW SAMPLES EACH TIME AND OBTAINED REACTIVE RESULTS. THE PATIENT'S TOXOPLASMOSIS GONDII IGG (ACCESS TOXO IGG) RESULTS WERE ALL NON-REACTIVE. THEREFORE, THE ACCESS TOXO IGM RESULTS WERE IN QUESTION BY THE PHYSICIAN. THE INITIAL, REACTIVE ACCESS TOXO IGM RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS THEN ADMINISTERED AN ANTIBIOTIC DUE TO THE REACTIVE ACCESS TOXO IGM RESULT OBTAINED. THE EXACT ANTIBIOTIC WAS NOT NAMED BY CUSTOMER. QUALITY CONTROL (QC) AND CALIBRATIONS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. NO ERRORS WERE POSTED TO THE INSTRUMENT'S EVENT LOG IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE SAMPLE COLLECTION AND PROCESSING INFORMATION SUCH AS TUBE TYPE, CENTRIFUGATION TIME AND CENTRIFUGATION SPEED.

  Patient problems: No Code Available

  MAUDE report 7922857 ↗