Atellica IM Toxo M 10995701Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414600147), received between Mar 30, 2022 and Jun 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023False Negative Result; False Negative Result

  A CUSTOMER REPORTED OBSERVATION OF A NEGATIVE ATELLICA IM TOXOPLASMA IGM (TOXO M) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL POSITIVE TOXOPLASMA IGM (TOXO M) RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPEAT-TESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER, WHICH PRODUCED A NEGATIVE RESULT. THE SAME SAMPLE WAS AGAIN REPEATED ON THE INITIAL ANALYZER AND PRODUCED A POSITIVE RESULT. THE SAME SAMPLE WAS THEN REPEATED ON THE SECOND ANALYZER, RETURNING A POSITIVE RESULT. THE POSITIVE RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE APPARENT FALSE NEGATIVE TOXO M RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116947 ↗
• MalfunctionMar 30, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED ATELLICA IM TOXOPLASMA IGM (TOXO M) NON-REACTIVE (NEGATIVE) RESULTS FROM FOUR SAMPLES THAT WERE CONSIDERED DISCORDANT COMPARED TO RESULTS GENERATED WITH A DIFFERENT LOT OF ATELLICA IM TOXOPLASMA IGM (TOXO M). THE RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, NON-REACTIVE ATELLICA IM TOXOPLASMA IGM (TOXO M) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957462 ↗