IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgG 10381268Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414964805), received between Dec 16, 2019 and Dec 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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.

• MalfunctionDec 16, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSE POSITIVE TOXOPLASMA IGG (TXP) RESULT WAS OBTAINED USING IMMULITE 1000. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND WAS REPEATED USING AN ALTERNATE NON-SIEMENS METHOD. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE TXP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9477353 ↗
• MalfunctionDec 16, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSE POSITIVE TOXOPLASMA IGG (TXP) RESULT WAS OBTAINED USING IMMULITE 1000. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND WAS REPEATED USING AN ALTERNATE NON-SIEMENS METHOD. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S).THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE TXP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9477335 ↗