Elecsys CMV IgG 07027117190Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630940172), received between Aug 23, 2021 and Sep 16, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR TWO PATIENTS TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 MODULE. 2. PATIENT AGE RANGE: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: ASKU 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066012 ↗
• MalfunctionMar 9, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS CMV IGG (CMV IGG) AND ELECSYS CMV IGM (CMV IGM) ON A COBAS E 801 MODULE. THIS MEDWATCH WILL COVER CMV IGG. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CMV IGM RESULTS. THE INITIAL CMV IGG RESULT FROM THE E801 MODULE WAS 0.180 U/ML (NEGATIVE). THE INITIAL CMV IGM RESULT FROM THE E801 MODULE WAS 0.239 COI (NEGATIVE). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WENT TO ANOTHER HOSPITAL. A NEW SAMPLE WAS OBTAINED AND THE CMV IGG AND CMV IGM RESULTS FROM THE CHORUS DIESSE METHOD WERE BOTH POSITIVE (THE ACTUAL RESULTS WERE NOT PROVIDED). THE ORIGINAL SAMPLE WAS SENT TO AN EXTERNAL LABORATORY FOR TESTING BY THE DIASORIN LIASON METHOD AND THE CMV IGG RESULT WAS 16.7 U/ML (POSITIVE) AND THE CMV IGM RESULT WAS 80.3 COI (POSITIVE). ON (B)(6)2023 THE CUSTOMER REPEATED THE ORIGINAL SAMPLE ON THE E801 MODULE AND THE CMV IGG RESULT WAS 0.181 U/ML (NEGATIVE) AND THE CMV IGM RESULT WAS 0.240 COI (NEGATIVE). ON (B)(6)2023 THE ORIGINAL SAMPLE WAS AGAIN REPEATED BY THE CUSTOMER WITH A CMV IGG RESULT OF 0.204 U/ML (NEGATIVE) AND A CMV IGM RESULT OF 0.241 COI (NEGATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516346 ↗
• MalfunctionJun 15, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGG ASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). THE SAMPLE RESULTED IN A CMV IGG VALUE OF 0.31 U/ML (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER. THE VALUE FROM THE E 801 ANALYZER WAS REPORTED OUTSIDE OF THE LABORATORY. AN ALIQUOT OF THIS SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING THE DIASORIN LIAISON XL METHOD, RESULTING IN A VALUE OF 104 U/ML (IMMUNE/REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694060 ↗
• MalfunctionApr 26, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT HAD TWO SAMPLES COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SAMPLES WERE REPEATED ON A VIDAS ANALYZER AND A LIAISON ANALYZER. ON (B)(6) 2022, THE PATIENT'S FIRST SAMPLE WAS COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULT WAS 2.5 U/ML POSITIVE. THE PATIENT'S VIDAS CMV IGG RESULT WAS 0.135 UA/ML NEGATIVE. ON (B)(6) 2022, THE PATIENT'S SECOND SAMPLE WAS COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULT WAS "<1" U/ML NEGATIVE. THE PATIENT'S VIDAS CMV IGG RESULT WAS 19 UA/ML POSITIVE. THE PATIENT'S LIAISON CMV IGG RESULT WAS 63 U/ML POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208719 ↗
• MalfunctionNov 23, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGG ASSAY ON A COBAS 8000 E 801 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED IN A (B)(6) IGG VALUE OF (B)(6) COI ((B)(6) ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS TESTED ON AN ABBOTT ARCHITECT ANALYZER, RESULTING IN A (B)(6) IGG VALUE THAT WAS 16 TIMES THE CUTOFF VALUE. THE REPORTER STATED THAT (B)(6) INFECTION OF THE PATIENT IS COMPATIBLE WITH THE PATIENT'S CLINICAL PICTURE. THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860026 ↗
• MalfunctionNov 11, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CMV IGG RESULT FOR ONE PATIENT SAMPLE WITH COBAS E 801 MODULE (B)(4). THE INITIAL RESULT WAS 1.20 U/ML (REACTIVE). THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE DOCTOR. ON (B)(6) 2021, THE SAMPLE WAS TESTED IN ANOTHER LABORATORY ON AN UNKNOWN ANALYZER WITH A RESULT OF NEGATIVE (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12793606 ↗
• MalfunctionSep 9, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED (B)(6) ELECSYS CMV IGG RESULTS FOR ONE PATIENT SAMPLE WITH THE COBAS E 801 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE PATIENT¿S ELECSYS RESULT WAS (B)(6). ON (B)(6) 2021, THE PATIENT¿S ELECSYS RESULT ON A SECOND SAMPLE WAS (B)(6). ON (B)(6) 2021, THE PATIENT¿S ELECSYS RESULT ON A THIRD SAMPLE WAS (B)(6). REPETITION USING THE ELECSYS, THE SAMPLE WAS (B)(6). REPETITION USING A VIDAS ANALYZER AT THE CUSTOMER¿S SITE, THE SAMPLE WAS (B)(6). IN ANOTHER LABORATORY WITH AN UNKNOWN METHOD, THE SAMPLE WAS (B)(6). THE (B)(6) RESULT WAS REPORTED TO THE PATIENT. IT IS UNKNOWN WHICH OF THE SAMPLES WAS TESTED IN THE OTHER LABORATORY OR USED FOR REPETITION TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447512 ↗
• MalfunctionAug 23, 2021Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CMV IGG ELECSYS RESULT FROM COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS <0.25 UI/ML(NEGATIVE). THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED BY DIASORIN METHOD WITH A RESULT OF 28.9 UI/ML (POSITIVE). ON (B)(6) 2021, THE SAME SAMPLE WAS RETESTED ON ANOTHER COBAS ANALYZER AND THE RESULT WAS <0.25 (NEGATIVE). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355709 ↗