Elecsys PTH STAT Immunoassay 4892470160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630939244), received between Oct 4, 2023 and Nov 22, 2023 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS PTH STAT IMMUNOASSAY (PTH STAT) DURING A SCHEDULED SURGERY TO REMOVE A PARATHYROID ADENOMA ON A COBAS 8000 E 602 MODULE. THE HIGH RESULTS ALLEGEDLY RESULTED IN A LONGER SURGERY AND ADDITIONAL TISSUE BEING REMOVED BY THE SURGEON. PTH HAD BEEN TESTED AT AN OUTSIDE LABORATORY BY AN UNKNOWN METHOD IN 2023 AND THE RESULT WAS REPORTEDLY 137 PG/ML. THE PATIENT ALLEGEDLY UNDERWENT REMOVAL OF THE ADENOMA WITH INITIAL DROP IN HER PARATHYROID LEVELS FROM 84 PG/ML TO 59 PG/ML. SINCE THE LEVEL REMAINED ELEVATED ADDITIONAL PARATHYROID TISSUE WAS SURGICALLY REMOVED ALONG WITH HALF OF HER THYROID AND HER THYMUS. SUBSEQUENTLY, TO WAS REPORTED THAT THE PATIENT UNDERWENT TESTING AT AN OUTSIDE LABORATORY ON A SIEMENS INSTRUMENT WITH A PARATHYROID HORMONE LEVEL OF LESS THAN 6.4 PG/ML. REPORTEDLY, THE PATIENT THEN UNDERWENT AN ADDITIONAL SURGERY TO REIMPLANT SOME OF HER PARATHYROID TISSUE INTO HER ABDOMEN TO PREVENT DEFICIENCY OF PARATHYROID HORMONE WHICH WAS SUCCESSFUL. ON AN UNKNOWN DATE, THE PATIENT REPORTEDLY WENT FOR A FOLLOW-UP LABORATORY TEST AT A DIFFERENT FACILITY AND THE PTH RESULT FROM COMPETITOR METHOD 1

  Patient problems: Hormonal Imbalance

  MAUDE report 18191411 ↗
• MalfunctionOct 4, 2023Mechanical Problem; Low Test Results; Non Reproducible Results; Mechanical Problem; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH ELECSYS PARATHYROID HORMONE (PTH) STAT ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER WHEN COMPARED TO A DIFFERENT COBAS E411 IMMUNOASSAY ANALYZER. INITIAL RESULT: < 1.2 PG/ML. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED. REPEAT RESULT: 208.4 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871237 ↗