Elecsys PTH 08928428190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613336170304), received between Oct 2, 2024 and Sep 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858830 ↗
• MalfunctionFeb 2, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PTH ELECSYS E2G 300 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MSB/MSBL MODULE COMPARED TO A COMPETITOR ANALYZER. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, PROMPTING THEM TO REPEAT THE SAMPLE. THE ROCHE RESULT WAS 37.5 PG/ML. THE COMPETITOR ABBOTT RESULT WAS 131.2 PG/ML. A 25% POLYETHYLENE GLYCOL (PEG) PRETREATMENT WAS PERFORMED ON THE SAMPLE AND RETESTED IN THE ROCHE ANALYZER, AND THE RESULT WAS 74.8 PG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239357 ↗
• MalfunctionOct 15, 2025Unable to Obtain Readings; Non Reproducible Results; Unable to Obtain Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE PTH ELECSYS E2G 300 RESULT FROM TWO OF THE COBAS E 801 ANALYTICAL UNITS FOR ONE PATIENT. THE INITIAL RESULT FROM THE COBAS E 801 ANALYZER UNIT A WAS 65.3 PG/ML, AND THE REPEAT RESULT ON THE COBAS E 801 ANALYZER UNIT B WAS 84.9 PG/ML. THE INITIAL RESULT WAS REPEATED BECAUSE A DOCTOR QUESTIONED THEM. THE REPEAT RESULT WAS DEEMED TO BE CORRECT. THE RESULT FROM ANOTHER HOSPITAL WAS 61.0 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303363 ↗
• MalfunctionSep 17, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PTH ELECSYS E2G RESULTS FROM THE COBAS E 801 MODULE. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 14.4 PG/ML. THE REPEAT RESULTS WERE 56.1 PG/ML AND 56.6 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073242 ↗
• MalfunctionSep 16, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE PTH ELECSYS E2G 300 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 402 ANALYTICAL UNIT. PATIENT SAMPLE 1: THE INITIAL RESULT WAS 10.8 PG/ML. THE REPEAT RESULT WAS 37.8 PG/ML. PATIENT SAMPLE 2: THE INITIAL RESULT WAS 13.7 PG/ML. THE REPEAT RESULT WAS 44.9 PG/ML. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE DEEMED LOW, PROMPTING THE RERUNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060874 ↗
• MalfunctionJul 30, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 4.47 PG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN PTH VALUES OF 35.8 PG/ML AND 36.3 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665196 ↗
• MalfunctionJul 25, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PTH ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS PRO SBL E 801 ANALYZER. ON (B)(6) 2025: THE INITIAL RESULT WAS 90 NG/ML. ON (B)(6) 2025: THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY, GENERATING A RESULT OF 50.9 NG/ML USING A DIFFERENT METHOD. ON (B)(6) 2025: FURTHER REPEAT TESTINGS WERE CONDUCTED AT MULTIPLE LABORATORIES WITH ALIQUOTS FROM THE SAME BLOOD SAMPLE; ONE LABORATORY REPORTED 70 NG/ML, ANOTHER REPORTED 38 NG/ML, AND ANOTHER REPORTED 50 NG/ML. IT WAS INDICATED THAT THE RESULTS DID NOT ALIGN WITH THE CLINICAL HISTORY OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608507 ↗
• MalfunctionMay 2, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PTH ELECSYS E2G 300 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1'S INITIAL RESULT ON (B)(6) 2025 WAS 7.30 PG/ML, AND THE REPEAT RESULT ON (B)(6) 2025 WAS 49.8 PG/ML. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 6.68 PG/ML, AND THE REPEAT RESULT WAS 50.6 PG/ML. A NEW SAMPLE WAS COLLECTED AND THE RESULTS WERE 47.1 PG/ML AND 48.3 PG/ML. THE INITIAL RESULT WAS CONSIDERED INCORRECT AND WAS REPEATED BECAUSE IT WAS A LOW RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949561 ↗
• MalfunctionApr 1, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SAMPLE TESTED FOR PTH ELECSYS E2G 300 (PTH) ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS < 6 PG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED, AND THE RESULT WAS < 6 PG/ML. A NEW SAMPLE WAS OBTAINED AND TESTED IN A PARTNER LABORATORY USING A COMPETITOR METHOD, AND THE RESULT WAS 22 PG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738717 ↗
• MalfunctionJan 24, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PTH ELECSYS E2G 300 RESULTS FOR 1 PATIENT ON A COBAS 8000 E 801 MODULE. AT 11:21 THE RESULT WAS 1060 PG/ML ON ANALYZER A. AT 16:48 THE RESULT WAS 1018 PG/ML ON ANALYZER B. ON (B)(6) 2025 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 273 PG/ML. IT IS UNKNOWN WHICH ANALYZER PRODUCED THE RESULT. THE SAMPLE WAS REPEATED DUE TO THE RESULTS NOT FITTING THE PATIENT'S CLINICAL PICTURE. A DRUG-RELATED INTERFERENCE IS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232393 ↗
• MalfunctionOct 2, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE PTH RESULTS WITH ONE PATIENT SAMPLE ON A COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 25.8 PG/ML USING THE SECONDARY TUBE. THE REPEAT RESULT WAS 523 PG/ML USING THE PRIMARY TUBE. THE SECOND REPEAT RESULT WAS 609 PG/ML USING THE SAME SECONDARY TUBE. THE THIRD REPEAT RESULT WAS 571 PG/ML USING A DIFFERENT SECONDARY TUBE. THE INITIAL RESULT DID NOT FIT THE PATIENT'S CLINICAL PICTURE, THEREFORE, THE REPEAT TESTINGS WERE PERFORMED. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352934 ↗