Elecsys Toxo IgG Immunoassay 4618815160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630939336), received between Aug 24, 2018 and Aug 24, 2018 — 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. 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.

• MalfunctionAug 24, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS TOXO IGG IMMUNOASSAY RESULTS FROM 2 SEPARATE SAMPLES (SAMPLE A AND SAMPLE B) FROM THE SAME PATIENT TESTED ON A COBAS 6000 E 601 MODULE COMPARED TO THE RESULTS FROM A COMPETITOR'S SYSTEM. THE COMPETITOR'S SYSTEM WAS BELIEVED TO BE AN ABBOTT. FOR SAMPLE A THE INITIAL TOXO IGG RESULT FROM A COBAS E601 WAS 119 IU/ML, POSITIVE. THE INITIAL RESULT WAS RELEASED TO THE DOCTOR BUT WAS QUESTIONED. THE PATIENT SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A COMPETITOR'S SYSTEM AND THE TOXO IGG RESULT WAS NEGATIVE. FOR SAMPLE B THAT WAS COLLECTED ON (B)(6) 2018, THE INITIAL TOXO IGG RESULT FROM A COBAS E601 WAS 118.6 IU/ML, POSITIVE. THE SAME SAMPLE WAS RETESTED AND THE INITIAL RESULT WAS CONFIRMED, NO SPECIFIC DETAILS PROVIDED. THE COBAS E601 SERIAL NUMBER WAS (B)(4). IT WAS NOTED THAT THE CUSTOMER WAS NOT FOLLOWING THE CALIBRATION AND QC TESTING FREQUENCY RECOMMENDED IN PRODUCT LABELING. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813447 ↗