Access Toxo IgG A31588Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15099590624927), received between Oct 27, 2016 and Oct 27, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2016False Positive Result; False Positive Result

  THE CUSTOMER REPORTED OBTAINING ELEVATED TOXOPLASMA GONDII IGG (ACCESS TOXO IGG) RESULTS FOR THREE (3) PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). FOR PATIENT 1, THE INITIAL ACCESS TOXO IGG RESULT RECOVERED EQUIVOCAL (GREY ZONE) ON (B)(6) 2016 AND WAS DISCORDANT WITH THE PATIENT'S CLINICAL FILE AND WITH ONE (1) ALTERNATE DEVICE, THE VIDAS MANUFACTURED BY BIOMÉRIEUX, WHICH PRODUCED A DISCORDANT NON-REACTIVE RESULT. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ONE (1) ADDITIONAL TIME ON (B)(6) 2016 ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED ONE (1) NON-REACTIVE RESULT. FOR PATIENT 2, THE INITIAL ACCESS TOXO IGG RESULT RECOVERED REACTIVE ON (B)(6) 2016. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE TWO (2) ADDITIONAL TIMES ON (B)(6) 2016 AND ON (B)(6) 2016 ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED TWO (2) REACTIVE RESULTS. THESE REACTIVE RESULTS WERE DISCORDANT WITH THE PATIENT'S CLINICAL FILE AND WITH ONE (1) ALTERNATE DEVICE, THE VIDAS MANUFACTURED BY BIOMÉRIEUX, WHICH PRODUCED A DISCORDANT NON-REACTIVE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6060199 ↗
• MalfunctionOct 27, 2016False Positive Result; False Positive Result

  THE CUSTOMER REPORTED OBTAINING ELEVATED TOXOPLASMA GONDII IGG (ACCESS TOXO IGG) RESULTS FOR THREE (3) PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). FOR PATIENT 1, THE INITIAL ACCESS TOXO IGG RESULT RECOVERED EQUIVOCAL (GREY ZONE) ON (B)(6) 2016 AND WAS DISCORDANT WITH THE PATIENT'S CLINICAL FILE AND WITH ONE (1) ALTERNATE DEVICE, THE VIDAS MANUFACTURED BY (B)(4), WHICH PRODUCED A DISCORDANT NON-REACTIVE RESULT. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ONE (1) ADDITIONAL TIME ON (B)(6) 2016 ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED ONE (1) NON-REACTIVE RESULT. FOR PATIENT 2, THE INITIAL ACCESS TOXO IGG RESULT RECOVERED REACTIVE ON (B)(6) 2016. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE TWO (2) ADDITIONAL TIMES ON (B)(6) 2016 THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED TWO (2) REACTIVE RESULTS. THESE REACTIVE RESULTS WERE DISCORDANT WITH THE PATIENT'S CLINICAL FILE AND WITH ONE (1) ALTERNATE DEVICE, THE VIDAS MANUFACTURED BY (B)(4), WHICH PRODUCED A DISCORDANT NON-REACTIVE RESULT. FOR PATIENT 3, THE INITIAL AC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6060191 ↗
• MalfunctionOct 27, 2016False Positive Result; False Positive Result

  THE CUSTOMER REPORTED OBTAINING ELEVATED TOXOPLASMA GONDII IGG (ACCESS TOXO IGG) RESULTS FOR THREE (3) PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). FOR PATIENT 1, THE INITIAL ACCESS TOXO IGG RESULT RECOVERED EQUIVOCAL (GREY ZONE) ON (B)(6) 2016 AND WAS DISCORDANT WITH THE PATIENT'S CLINICAL FILE AND WITH ONE (1) ALTERNATE DEVICE, THE VIDAS MANUFACTURED BY (B)(4), WHICH PRODUCED A DISCORDANT NON-REACTIVE RESULT. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE ONE (1) ADDITIONAL TIME ON (B)(6) 2016 ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED ONE (1) NON-REACTIVE RESULT. FOR PATIENT 2, THE INITIAL ACCESS TOXO IGG RESULT RECOVERED REACTIVE ON (B)(6) 2016. THE CUSTOMER REANALYZED THE PATIENT'S SAMPLE TWO (2) ADDITIONAL TIMES ON (B)(6) 2016 AND ON (B)(6) 2016 ON THE SAME LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) AND OBTAINED TWO (2) REACTIVE RESULTS. THESE REACTIVE RESULTS WERE DISCORDANT WITH THE PATIENT'S CLINICAL FILE AND WITH ONE (1) ALTERNATE DEVICE, THE VIDAS MANUFACTURED BY (B)(4), WHICH PRODUCED A DISCORDANT NON-REACTIVE RESULT. FOR PAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6060188 ↗