Elecsys HSV2 IgG Immunoassay 5572193160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630939053), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF (B)(6) RESULTS FOR 1 PATIENT TESTED FOR ELECSYS HSV-1 IGG IMMUNOASSAY (HSV-1) AND ELECSYS HSV-2 IGG IMMUNOASSAY (HSV-2) ON A COBAS 8000 E 602 MODULE. THIS MEDWATCH WILL COVER (B)(6). REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE (B)(6) RESULTS. ON (B)(6) 2018 THE PATIENT WAS "(B)(6)" BY A POLYMERASE CHAIN REACTION (PCR) TEST FOR (B)(6); THE ACTUAL RESULTS WERE NOT PROVIDED. THE SAME DAY THE PATIENT WAS TESTED BY AN IMMULITE ANALYZER AND THE (B)(6) RESULTS WERE (B)(6). ON (B)(6) 2018 A NEW SAMPLE WAS OBTAINED AND THE PATIENT HAD A "(B)(6)" PCR RESULT FOR (B)(6); THE ACTUAL RESULTS WERE NOT PROVIDED. THE SAMPLE FROM (B)(6) 2018 WAS TESTED ON THE IMMULITE ANALYZER AND THE (B)(6) RESULTS WERE (B)(6). THE SAME SAMPLE WAS TESTED ON THE E602 MODULE AND THE (B)(6) RESULT WAS (B)(6) AND THE (B)(6) RESULT WAS (B)(6). THE LABORATORY TOOK THE SAMPLE FROM (B)(6) 2018 AND RAN ADDITIONAL TESTS FOR IGM BY THE ELISA METHOD. THE (B)(6) RESULT WAS (B)(6) AND THE (B)(6) RESULT WAS "(B)(6)" (ACTUAL RESULT NOT PROVIDED). THE (B)(6) TEST RESULT FROM THE VECTOR-BEST METHOD WAS (B)(6). THE (B)(6) RESULTS FROM THE E602 MODULE WERE REPORTED OUTSIDE OF THE LABORATORY. THERE W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906288 ↗