Elecsys PTHRecalls & reported problems across all models

We found 2 models of Elecsys PTH by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2021 and Sep 22, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys PTH problems

Elecsys PTH models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys PTH 07251068190

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  21 reports
• Elecsys PTH 08928428190

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  11 reports

Recent Elecsys PTH adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionNov 24, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT AND A COBAS E 602 MODULE. OVER A LONG PERIOD OF MONITORING, THE PATIENT HAS HAD A PTH CONCENTRATION IN THE NORMAL REFERENCE RANGE OF 15 - 65 PG/ML. THE SAMPLE RESULTED IN PTH VALUES OF 25.1 PG/ML, 24.4 PG/ML, 25.9 PG/ML, AND 19.9 PG/ML WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS TREATED WITH A 25% POLYETHYLENE GLYCOL (PEG) SOLUTION IN A 1:1 RATIO, RESULTING IN PTH VALUES OF 40.2 PG/ML (160.16 % RECOVERY) AND 51.8 PG/ML ON THE E 801 ANALYZER. THE SAMPLE WAS DILUTED 1:2 AND TESTED ON THE E801 SYSTEM, RESULTING IN A RAW PTH VALUE OF 9.34 PG/ML WHICH CALCULATED TO A FINAL VALUE OF 18.68 PG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS DILUTED 1:4 AND TESTED ON THE E801 SYSTEM, RESULTING IN A RAW PTH VALUE OF 5.85 PG/ML WHICH CALCULATED TO A FINAL VALUE OF 23.4 PG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS DILUTED 1:8 AND TESTED ON THE E801 SYSTEM, RESULTING IN A RAW PTH VALUE OF 5.68 PG/ML WHICH CALCULATED TO A FINAL VALUE OF 45.44 PG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS DILUTED 1:16 AND TES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632039 ↗
• 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 ↗
• MalfunctionOct 15, 2025Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 65.3 PG/ML WHEN TESTED ON THE FIRST E 801 ANALYZER. THE DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. WHEN REPEATED ON A SECOND E 801 ANALYZER, THE RESULT WAS 84.9 PG/ML. WHEN REPEATED ON A THIRD E 801 ANALYZER, THE RESULT WAS 61.0 PG/ML. THE CUSTOMER DEEMED THE PTH VALUE OF 84.9 PG/ML TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294953 ↗
• 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 ↗
• MalfunctionAug 27, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PTH RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 451 PG/ML. THIS RESULT WAS DEEMED ELEVATED. THE REPEAT RESULT FROM A BECKMAN I800 PLATFORM WAS 2.5 PMOL/L. THIS RESULT WAS WITHIN THE NORMAL RANGE. THE REPORTER PERFORMED A SERIAL DILUTION: THE REPEAT RESULT AT 2X DILUTION WAS 452 PG/ML. THE REPEAT RESULT AT 4X DILUTION WAS 476 PG/ML. THE REPEAT RESULT AT 8X DILUTION WAS 517.6 PG/ML. THE REPEAT RESULT AT 16X DILUTION WAS 553.6 PG/ML. THE REPEAT RESULT AT 32X DILUTION WAS 601.6 PG/ML THE REPORTER NOTED THAT THE SERIAL DILUTION RESULTS HAD NO DILUTION LINEARITY. THE REPORTER SUSPECTS A SAMPLE-SPECIFIC INTERFERENT IN THE PATIENT SAMPLE BASED ON THE CLINICAL AND LABORATORY FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902393 ↗
• 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 ↗
• MalfunctionJun 6, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PARATHYROID HORMONE (PTH) ASSAY ON A COBAS PRO SSU ANALYZER. INITIAL RESULT: 455 PG/ML (TESTED ON THE CUSTOMER'S E801 ANALYZER). TWO OTHER TUBES WERE DRAWN FROM THE PATIENT AT THE SAME TIME: TUBE 2 AND TUBE 3. THE CUSTOMER PROVIDED TUBE 2 AND TUBE 3 FOR INVESTIGATION, WHERE THEY WERE TESTED ON 13-MAY-2025 ON A 2ND E801 ANALYZER: TUBE 2 RESULTS WERE 332 PG/ML AND 325 PG/ML. TUBE 3 RESULT WAS 321 PG/ML. ON 14-MAY-2025, TUBE 2 WAS ALSO REPEATED ON E801 AT THE INVESTIGATION SITE, AND THE REPEAT RESULT WAS 319 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160779 ↗
• InjuryMay 16, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED THAT THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT'S SURGERY WAS ALLEGEDLY STOPPED DUE TO A REPORTED INCORRECT PTH VALUE. A FIRST SAMPLE COLLECTED FROM THE PATIENT REPORTEDLY RESULTED IN A PTH VALUE OF 118 PG/ML. DURING THE SURGERY, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS LOADED INTO A SAMPLE CUP AND TESTED, REPORTEDLY RESULTING IN A PTH VALUE OF 5.94 PG/ML. THE PATIENT'S SURGERY WAS ALLEGEDLY STOPPED DUE TO THIS VALUE. THE SECOND SAMPLE WAS THEN REPEATED, REPORTEDLY RESULTING IN A PTH VALUE OF 125 PG/ML. IT WAS REPORTED THAT THIS REPEAT VALUE WAS REPORTED TO THE PHYSICIAN. A THIRD SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025 AND TESTED TWICE, REPORTEDLY RESULTING IN PTH VALUES OF 112 PG/ML AND 99.9 PG/ML. THE PATIENT ALLEGEDLY HAD A SECOND SURGERY PERFORMED ON (B)(6) 2025 AND THE SITUATION IS REPORTED TO BE STABILIZED. SAMPLES COLLECTED DURING THIS SURGERY WERE ALLEGEDLY SENT TO AN EXTERNAL LABORATORY FOR TESTING. THE CUSTOMER ALLEGED THAT THERE WERE DIFFERENCES BETWEEN RESULTS OF THE SAME SAMPLES SENT TO THE EXTERNAL LABORATORY AND THE RESULTS OBTAINED WITH

  Patient problems: Insufficient Information

  MAUDE report 22035167 ↗
• 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 ↗

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