Elecsys Troponin I Immunoassay 5094810160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630939374), received between Feb 14, 2022 and Jun 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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-1596-2021 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionJun 13, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN I IMMUNOASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE. THE E 601 MODULE SERIAL NUMBER WAS (B)(4). PRIOR TO PATIENT TESTING, THE CUSTOMER REPORTED THE TROPONIN QC WAS ACCEPTABLE. THE PATIENT'S INITIAL ELECSYS TROPONIN RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN QUESTIONED THE REPORTED TROPONIN RESULT AND THE CUSTOMER PERFORMED REPEAT TESTING. IT WAS REPORTED THE PATIENT HAD A NEW SAMPLE COLLECTED "MULTIPLE TIMES" OVER A PERIOD OF THREE DAYS AND THE SAME RESULTS WERE OBTAINED. THE PATIENT'S PHYSICIAN REPORTED THE ELECSYS TROPONIN RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND THE CREATININE KINASE (CKMB) RESULT. A SAMPLE FROM THE PATIENT WAS SENT TO A DIFFERENT LABORATORY AND TESTED ON A SIEMENS ANALYZER. THE PATIENT'S INITIAL ELECSYS TROPONIN RESULT WAS 0.629 NG/ML. THE PATIENT'S FIRST REPEAT ELECSYS TROPONIN RESULT WAS 0.58 NG/ML. THE PATIENT'S SECOND REPEAT ELECSYS TROPONIN RESULT WAS 0.615 NG/ML. THE PATIENT'S NEW SAMPLE HAD A NEGATIVE TROPONIN RESULT ON A SIEMENS ANALYZER. THE EXACT RESULT WAS REQUESTED BUT NOT PROVIDED. THE TROPONIN RESULT FROM THE SIEMENS ANALYZER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675133 ↗
• MalfunctionFeb 14, 2022Low Test Results; Non Reproducible Results; Low Test 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). THE REPORTER SENT THE SAMPLE TO A PARTNER LABORATORY FOR TESTING. THIS LABORATORY ALSO USES A ROCHE MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN DID NOT AGREE WITH THE RESULT AND FURTHER TESTING WAS PERFORMED IN TWO EXTERNAL LABORATORIES. THE REPORTER MENTIONED THREE SAMPLES. SAMPLE 1 WAS THE INITIAL SAMPLE AND WAS SENT TO THE PARTNER LABORATORY. SAMPLE 2 WAS SENT TO THE FIRST LABORATORY AND SAMPLE 3 WAS SENT TO A SECOND EXTERNAL LABORATORY. IT WAS NOT CLEAR IF THE SAMPLES TESTED IN THE TWO EXTERNAL LABORATORIES WAS THE INITIAL SAMPLE. THE REPORTER HAS NOT RESPONDED TO AN INQUIRY REGARDING THE DETAILS OF THE SAMPLES TESTED IN THE EXTERNAL LABORATORIES. ON (B)(6) 2022, SAMPLE 1 HAD AN INITIAL RESULT FROM THE MODULE WAS 0.131 UG/L. SAMPLE 2 HAD A RESULT OF 1032.60 NG/L FROM THE FIRST EXTERNAL LABORATORY. ON (B)(6) 2022, SAMPLE 3 HAD A RESULT OF 1223.31 NG/L FROM THE SECOND EXTERNAL LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525243 ↗

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-1595-2021 · Apr 7, 2021 · Open, Classified
  Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
• 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
• 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