Elecsys CK-MB 07027087190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630939978), received between Mar 23, 2023 and Sep 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 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.

• MalfunctionSep 17, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805776 ↗
• MalfunctionJun 6, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CK-MB ELECSYS E2G RESULT FROM AN UNKNOWN ROCHE ANALYZER. THERE WAS AN ALLEGATION THAT MACRO-CK WAS INTERMITTENTLY DETECTED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073474 ↗
• MalfunctionMar 23, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CK-MB (CK-MB) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 83.8 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE CK-MB RESULT WAS 1.65 NG/ML. THE CUSTOMER NOTED THAT THE INITIAL CK-MB RESULT WAS GREATER THAN THE PATIENT'S INITIAL CK RESULT AND PULLED THE ORIGINAL SAMPLE FOR RE-TESTING. ON (B)(6) 2023 THE ORIGINAL SAMPLE WAS REPEATED WITH A CK-MB RESULT OF 2.52 NG/ML. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600627 ↗