Elecsys Troponin I STAT Immunoassay 5094798160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630939381), received between Aug 1, 2018 and Feb 1, 2022 — classified as 3 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K082699); 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.

Recalls naming this device

1. Apr 7, 2021Class IIOpen, Classified

   Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

   Z-1595-2021 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionFeb 1, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN I STAT IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 E 601 MODULE WITH SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. ON THE SAME DAY, THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY WHERE A NEGATIVE UNSPECIFIED TROPONIN RESULT WAS OBTAINED ON A NEW SAMPLE FROM THE PATIENT. THE PATHOLOGIST OF THE LABORATORY ALSO QUESTIONED THE RESULT AND REQUESTED THAT THE INITIAL PLASMA SAMPLE BE SENT TO ANOTHER LABORATORY FOR A RERUN. THE LABORATORY USES A VITROS ANALYZER WITH AN UNKNOWN LABORATORY METHOD. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT OF THE PLASMA SAMPLE IN A PRIMARY TUBE AT 8:40 AM WAS 2.8 NG/ML. THE REPEAT RESULT OF THE PLASMA ALIQUOT SAMPLE FROM THE OTHER LABORATORY WAS <0.012 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417626 ↗
• MalfunctionSep 13, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TROPONIN I STAT IMMUNOASSAY RESULTS FROM COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 1.59 NG/ML (POSITIVE) AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 1.57 NG/ML (POSITIVE). THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE RESULTS. THE PATIENT WAS TESTED USING AN ABBOTT I-STAT AND THE RESULT WAS 0.02 NG/ML (NEGATIVE). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FIELD SERVICE REPRESENTATIVE INSPECTED THE INSTRUMENT AND GEAR PUMP PRESSURE, CHECKED THE PROBE ALIGNMENTS AND SPLINE SET SCREWS. HE PERFORMED A PRECISION CHECK, MECHANICAL CHECK, AND OPERATIONAL CHECKS WHICH ALL PASSED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872794 ↗
• MalfunctionAug 1, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF ERRONEOUS HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS TROPONIN I STAT IMMUNOASSAY (TROPONIN I STAT) ON 2 COBAS 6000 E 601 MODULES. THE E601 MODULE SERIAL NUMBERS WERE (B)(4). PATIENT 1 INITIAL RESULT FROM THE E601 MODULE WAS 3.35 NG/ML. PATIENT 2 (MALE, DATE OF BIRTH (B)(6)) INITIAL RESULT FROM THE E601 MODULE WAS 2.08 NG/ML. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE MEDICAL PERSONNEL QUESTIONED THEM. BOTH PATIENT SAMPLES WERE REPEATED BY THE ISTAT METHOD AND THE ORTHO-VITROS METHOD WITH NEGATIVE RESULTS (0.0 NG/ML). THE CUSTOMER REPEATED BOTH PATIENT SAMPLES ON A DIFFERENT E601 MODULE AND OBTAINED "POSITIVE" RESULTS AGAIN. THE ACTUAL RESULTS WERE NOT PROVIDED. THE SAMPLES WERE REPEATED AGAIN BY THE ISTAT METHOD WITH NEGATIVE RESULTS (0.0 NG/ML). THE NEGATIVE RESULTS FROM THE ISTAT AND ORTHO-VITROS METHODS WERE BELIEVED TO BE CORRECT. THE CUSTOMER DID NOT HAVE ISSUES WITH ANY OTHER PATIENTS TESTED FOR TROPONIN I STAT ON THE E601 MODULES. THE CUSTOMER THINKS THERE MAY BE SOME SORT OF INTERFERENCE IN THESE PATIENT SAMPLES AFFECTING THE RESULTS FROM THE E601 MODULES. NO ADVERSE EVENT OCCURRED. THE FIELD SERVICE ENGINEER (FSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082699. One submission often covers many models, so check the product and lot details in each record.

• Z-1596-2021 · Apr 7, 2021 · Open, Classified
  Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
• Z-1388-2012 · Mar 12, 2012 · Terminated
  Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagn
• Z-1387-2012 · Mar 12, 2012 · Terminated
  Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis