Elecsys PTH Immunoassay 11972103160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630939237), received between Jan 28, 2019 and Nov 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K070709, K992680); they may or may not involve this specific model.

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.

• MalfunctionNov 11, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PTH RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1: THE INITIAL RESULT WAS 1276 PG/ML AND THE REPEATED RESULT WAS 1289 PG/ML. SAMPLE 2: THE INITIAL RESULT WAS 10.26 PG/ML AND THE REPEATED RESULT WAS 1041 PG/ML. SAMPLE 3: THE INITIAL RESULT WAS 1296 PG/ML AND THE REPEATED RESULT WAS 1314 PG/ML. SAMPLE 4: THE INITIAL RESULT WAS 968.6 PG/ML AND THE REPEATED RESULT WAS 1003 PG/ML. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED AS THE INITIAL RESULT FROM THE SECOND SAMPLE WAS MUCH LOWER THAN EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653933 ↗
• MalfunctionJan 29, 2019Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS ELECSYS PTH IMMUNOASSAY RESULTS WERE GENERATED. THE EVENTS INVOLVED A TOTAL OF 9 PATIENTS. THE PATIENTS' AGES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' GENDERS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285292 ↗
• MalfunctionJan 28, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENT INVOLVED A TOTAL OF 26 PATIENTS WITH ERRONEOUS RESULTS FOR ELECSYS PTH IMMUNOASSAY. THE PATIENTS' AGES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THERE PATIENTS' GENDERS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8281625 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070709, K992680. One submission often covers many models, so check the product and lot details in each record.

• Z-0810-2007 · Apr 19, 2007 · Terminated
  Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103