Elecsys CMV IgG 09118551190Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07613336198469), received between Nov 14, 2022 and Aug 12, 2026 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (16 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226289 ↗
• MalfunctionAug 12, 2026Low Test Results

  There was an allegation of questionable Elecsys CMV IgG and Elecsys CMV IgM results for 1 patient on a cobas e 801 analytical unit compared to a Vidas analyzer.This Medwatch will cover CMV IgG. Refer to Medwatch with A1 patient identifier (b)(6) for information on the CMV IgM results.On (b)(6) 2025, the patient had a CMV IgG result of 0.38 U/mL (negative) and a CMV IgM result of 0.69 COI (negative).On (b)(6) 2026, the patient had a CMV IgG result of 3.68 U/mL (positive) and a CMV IgM result of 0.657 COI (negative).On (b)(6) 2026, the customer repeated the previous patient samples.The sample from on (b)(6) 2025 gave a CMV IgG result of 0.37 U/mL (negative) and a CMV IgM result of 0.789 COI (equivocal).The sample was also sent to another laboratory and tested on a Vidas analyzer and the CMV IgG result was 20 (positive) and the CMV IgM result was 33.6 (positive).The sample from on (b)(6) 2026 gave a CMV IgG result of 3.69 U/mL (positive) and a CMV IgM result of 0.718 COI (equivocal).The sample was also sent to another laboratory and tested on a Vidas analyzer and the CMV IgG result was 19 (positive) and the CMV IgM result was 24 (positive).The Vidas analyzer results units of measureme

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224800 ↗
• MalfunctionAug 6, 2026False Positive Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161483 ↗
• MalfunctionJul 16, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25835832 ↗
• InjuryMay 13, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CMV IGG RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A DIASORIN ANALYZER. FOR INFORMATION RELATED TO THE CMV IGM ASSAY, PLEASE REFER TO MFG REPORT 1823260-2026-01549 THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. ON (B)(6) 2025, THE CMV IGM RESULT WAS 0.48 IU/ML (NEGATIVE) AND THE CMV IGG RESULT WAS 3.91 IU/ML (POSITIVE). THE PATIENT WAS 9 WEEKS AND 2 DAYS PREGNANT, AND THE RESULTS INDICATED CMV IMMUNITY. WHEN THE PATIENT WAS 22 WEEKS PREGNANT, SEVERE FETAL BRAIN ABNORMALITIES WERE DETECTED SUGGESTING FETAL CYTOMEGALOVIRUS INFECTION. AMNIOCENTESIS WAS PERFORMED AND CMV PCR IN AMNIOTIC FLUID GAVE A POSITIVE RESULT, CONFIRMING FETAL CMV INFECTION. THE SEVERITY OF THE BRAIN LESIONS WAS CONFIRMED BY MRI OF THE FETAL BRAIN AND TERMINATION OF PREGNANCY WAS PERFORMED. THE PATIENT SAMPLE FROM (B)(6) 2025 WAS RETESTED ON A DIASORIN ANALYZER AND THE CMV IGM RESULT WAS 51.7 IU/ML (POSITIVE) AND THE CMV IGG RESULT WAS <5 IU/ML (NEGATIVE). THE EXACT DATE OF TESTING WAS NOT PROVIDED. ON (B)(6) 2026, THE SAMPLE FROM (B)(6) 2025 WAS REPEATED ON LINE 1 OF THE COBAS ANALYZER AND THE CMV IGM RESULT WAS 0.51 (NEGATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163961 ↗
• MalfunctionApr 8, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT WHEN COMPARED TO COMPETITOR METHODS. THE PATIENT WAS FIRST TESTED ON (B)(6) 2026 WITH THE FOLLOWING RESULTS: THE RESULT FROM THE E801 ANALYZER WAS 1.27 IU/ML (POSITIVE). THE RESULT FROM THE ABBOTT METHOD WAS 68.7 UA/ML (POSITIVE). THE RESULT FROM THE DIASORIN METHOD WAS 88.6 U/ML (POSITIVE). THE CMV IGG AVIDITY RESULT FROM THE VIDAS METHOD WAS 43% (MODERATE). THE DIASORIN PARVOVIRUS B19 RESULT WAS 54.90 U/ML (POSITIVE). A NEW SAMPLE WAS OBTAINED ON (B)(6) 2026 WITH THE FOLLOWING RESULTS: THE RESULT FROM THE E801 ANALYZER WAS 0.967 IU/ML (INDETERMINATE). THE RESULT FROM THE ABBOTT METHOD WAS 77.8 UA/ML (POSITIVE). THE CMV IGG AVIDITY RESULT FROM THE VIDAS METHOD WAS 45% (MODERATE). A NEW SAMPLE WAS OBTAINED ON (B)(6) 2026 WITH THE FOLLOWING RESULTS: THE RESULT FROM THE E801 ANALYZER WAS 0.590 IU/ML (INDETERMINATE). THE RESULT FROM THE ABBOTT METHOD WAS 79 UA/ML (POSITIVE). THE RESULT FROM THE DIASORIN METHOD WAS 90.8 U/ML (POSITIVE). THE CMV IGG AVIDITY RESULT FROM THE VIDAS METHOD WAS 46% (MODERATE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818675 ↗
• MalfunctionMar 9, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE POSITIVE ELECSYS CMV IGG RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2026: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE COLLECTED ON (B)(6) 2026 WAS 7.69 U/ML (POSITIVE). ON (B)(6) 2026: THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE FROM ANOTHER ANALYZER WAS <0.150 U/ML WITH A DATA FLAG (NEGATIVE). ON (B)(6) 2026, A NEW SAMPLE WAS OBTAINED, AND THE RESULT FROM THE OTHER ANALYZER WAS <0.150 U/ML WITH A DATA FLAG (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552078 ↗
• MalfunctionJan 15, 2026False Positive Result; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 7.57 U/ML (REACTIVE). THE REPEAT RESULT WAS CONSISTENTLY 0.15 U/ML (NON-REACTIVE) UPON TESTING FIVE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077914 ↗
• MalfunctionJan 14, 2026False Negative Result; Low Test Results

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE ELECSYS CMV IGG RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. PLEASE SEE THE ATTACHMENT "(B)(6)" FOR THE PATIENT'S RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067106 ↗
• MalfunctionDec 11, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FROM THE COBAS E 801 MODULE. THE RESULT FOR A DONOR SAMPLE MEASURED ON (B)(6) 2025, HAD A RESULT OF < 0.150 U/ML WITH A DATA FLAG (NON-REACTIVE). TESTING OF BOTH EXISTING RETENTION SAMPLES FROM THE SAME DONOR/SAME DRAW HAD A RESULT OF > 500 U/ML WITH A DATA FLAG (REACTIVE). THE REPEAT RESULT WAS EXPECTED DUE TO EARLIER SCREENING RESULTS FOR THIS DONOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778187 ↗
• MalfunctionDec 3, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED A HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL CMV IGG RESULT FROM THE E801 ANALYZER WAS 12.1 U/ML (POSITIVE). FOR CONFIRMATION, THE SAMPLE WAS SENT TO 2 EXTERNAL LABORATORIES, WHERE THE CMV IGG RESULTS FROM 3 COMPETITOR METHODS WERE: ABBOTT ALINITY: < 6 (UNIT OF MEASURE NOT PROVIDED); NEGATIVE. DIASORIN LIAISON: < 5 (UNIT OF MEASURE NOT PROVIDED); NEGATIVE. VIDAS BIOMÉRIEUX: < 4 (UNIT OF MEASURE NOT PROVIDED); NEGATIVE. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON THE E801 ANALYZER, AND THE RESULT WAS "POSITIVE." THE SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706928 ↗
• MalfunctionDec 2, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM AND ELECSYS CMV IGG RESULTS FROM ONE PATIENT FROM THE COBAS E 801 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CMV IGG ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CMV IGM ASSAY. SAMPLE 1 (B)(6) 2025) AT 10 WEEKS OF PREGNANCY: THE ELECSYS CMV IGM RESULT WAS 0.38 COI WITH A DATA FLAG (NEGATIVE). THE ELECSYS CMV IGG RESULT WAS 0.150 U/ML WITH A DATA FLAG (NEGATIVE). ON (B)(6) 2025, THE DIASORIN LIAISON CMV IGM RESULT WAS 23.1 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG RESULT WAS 48 UA/ML (POSITIVE). THE DIASORIN LIAISON CMV IGG AVIDITY RESULT WAS 0.0493. THE VIDAS BIOMÉRIEUX CMV IGG RESULT WAS <6 UA/ML (GREYZONE/EQUIVOCAL). ON (B)(6) 2025, THE REPEAT ELECSYS CMV IGM RESULT USING REAGENT LOT 848029 WAS 0.40 COI (NEGATIVE). ELECSYS CMV IGG RESULT USING REAGENT LOT 836250 WAS 0.150 U/ML WITH A DATA FLAG (NEGATIVE). SAMPLE 2 (B)(6) 2025) 19 WEEKS OF PREGNANCY: THE ELECSYS CMV IGM RESULT WAS 2.72 COI. THE REPEAT RESULT WAS 2.67 COI (POSITIVE). THE ELECSYS CMV IGG RESULT WAS 10.8 U/ML. THE REPEAT RESULT WAS 10.6 U/ML (POSITIVE). ON (B)(6) 2025, THE DIASORIN LIAISON CMV IGM RESULT WAS 25.4 UA/ML (POSIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696221 ↗
• MalfunctionNov 5, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FROM MULTIPLE SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE FROM (B)(6) 2025: THE CMV IGG RESULT FROM THE E801 ANALYZER WAS 0.61 U/ML (BORDERLINE). THIS SAMPLE WAS TESTED BY 2 COMPETITOR METHODS: DIASORIN LIAISON CMV IGG: 20.4 AU/ML (POSITIVE) DIASORIN LIAISON CMV IGG AVIDITY: IGG TOO LOW (AVIDITY NOT INTERPRETABLE) BIOMÉRIEUX VIDAS CMV IGG: 9 AU/ML (POSITIVE) BIOMÉRIEUX VIDAS CMV IGG AVIDITY: 8 AVI% THE RESULTS SUGGEST A RECENT PRIMARY CMV INFECTION. SAMPLE FROM (B)(6) 2025: THE CMV IGG RESULT FROM THE E801 ANALYZER WAS 0.276 U/ML (NEGATIVE). SAMPLE FROM (B)(6) 2025: ON (B)(6) 2025, THE CMV IGG RESULT WAS 0.28 U/ML (NEGATIVE). ON (B)(6) 2025, THE REPEAT RESULT WAS 0.260 U/ML (NEGATIVE). THIS SAMPLE WAS TESTED BY 2 COMPETITOR METHODS: DIASORIN LIAISON CMV IGG: 39.3 AU/ML (POSITIVE). DIASORIN LIAISON CMV IGG AVIDITY: 0.105 BIOMÉRIEUX VIDAS CMV IGG: 16 AU/ML (POSITIVE). BIOMÉRIEUX VIDAS CMV IGG AVIDITY: 28 AVI% THE RESULTS CONFIRM A RECENT PRIMARY INFECTION WITH CMV. THE CUSTOMER SUSPECTS A MISSED SEROCONVERSION OF THE ROCHE CMV IGG ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478678 ↗
• MalfunctionNov 3, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 0.0 U/ML (INTERPRETED AS NEGATIVE). REPEAT RESULT: 125.0 U/ML (TESTED WITH ABBOTT CMV IGG AND INTERPRETED AS POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453463 ↗
• MalfunctionNov 3, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS WITH A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025: THE RESULT WAS NON-REACTIVE. ON (B)(6) 2025: THE RESULT WAS 235 U/ML (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450692 ↗
• MalfunctionOct 16, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL CMV IGG RESULT WAS 12 COI (REACTIVE). PATIENT 2 INITIAL CMV IGG RESULT WAS 3.5 COI (REACTIVE). BOTH SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT (CHORUS EVO DIESSE, ELISA METHOD), DUE TO A PREVIOUS NEGATIVE CMV IGG HISTORY FOR BOTH PATIENTS. THE RESULTS OBTAINED ON THE ELISA SYSTEM WERE NEGATIVE: PATIENT 1: < 0.20, PATIENT 2: < 0.20. FOLLOWING THIS, A RERUN WAS PERFORMED ON THE ORIGINAL COBAS INSTRUMENT AFTER RECALIBRATION: PATIENT 1: CMV IGG = 12 COI (REACTIVE). PATIENT 2: CMV IGG = 3.5 COI (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310267 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR TWO PATIENTS TESTED WITH ELECSYS CMV IGG ON A COBAS PURE E 402 ANALYTICAL UNIT AND A COBAS E 801 MODULE. 2. PATIENT AGE RANGE: 2 ASKU. 3. PATIENT WEIGHT RANGE: 2 ASKU. 4. PATIENT SEX BREAKDOWN: 2 ASKU. 5. PATIENT RACE BREAKDOWN: 2 ASKU. 6. PATIENT ETHNICITY BREAKDOWN: 2 ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066069 ↗
• MalfunctionJul 15, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF 0.150 U/ML (NON-REACTIVE) AND IT REPEATED AS 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CMIA METHOD, RESULTING IN A CMV IGG VALUE OF 52.5 AIU/ML (POSITIVE) ON (B)(6) 2025. THE SECOND SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF < 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CMIA METHOD, RESULTING IN A CMV IGG VALUE OF 9.10 AIU/ML (POSITIVE). THE THIRD SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF < 0.150 U/ML (NON-REACTIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING A CMIA METHOD, RESULTING IN A CMV IGG VALUE OF 3.82 AIU/ML (POSITIVE). THE POSITIVE SAMPLE VALUES WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508125 ↗
• MalfunctionJun 25, 2025False Negative Result; High Test Results; False Negative Result; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG AND ELECSYS CMV IGM ON A COBAS E 801 ANALYTICAL UNIT. THE RESULTS WERE DISCREPANT FROM RESULTS OBTAINED WITH A COMPETITOR METHOD (ABBOTT ALINITY). THIS MEDWATCH WILL APPLY TO THE ELECSYS CMV IGG ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS CMV IGM ASSAY. THE SAMPLE WAS FIRST TESTED ON (B)(6) 2022 USING THE ABBOTT ALINITY METHOD, RESULTING IN THE FOLLOWING VALUES: CMV IGG = 2.5 AU/ML (NEGATIVE), CMV IGM = 9.25 INDEX (POSITIVE). THE SAMPLE WAS REPEATED ON (B)(6) 2025 USING THE E 801 ANALYZER, RESULTING IN THE FOLLOWING VALUES: CMV IGG = 2.62 U/ML (POSITIVE), CMV IGM = 0.42 COI (NEGATIVE). ACCORDING TO THE CUSTOMER, THE PATIENT IS A "TRUE" POSITIVE FOR CMV IGM AND NEGATIVE FOR CMV IGG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326958 ↗
• MalfunctionJun 9, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED A NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE E801 ANALYZER WAS 0.496 U/ML (NEGATIVE). THE SAMPLE WAS REPEATED TWICE ON THE ANALYZER WITH RESULTS OF 0.480 U/ML (NEGATIVE) AND 0.478 U/ML (NEGATIVE). THE SAMPLE WAS REPEATED USING A COMPETITOR METHOD, AND THE RESULT WAS 15 U/ML (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167673 ↗
• MalfunctionMay 9, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FOR 4 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). ON (B)(6) 2024, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 22.770 UI/ ML (REACTIVE). THE AVIDITY WAS 98.9 %. PATIENT 2: ON (B)(6) 2025, THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). THE CMV IGM RESULT WAS 0.345 COI (NON-REACTIVE). ON (B)(6) 2024, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 14.14 UI/ML (REACTIVE). PATIENT 3: ON (B)(6) 2025, THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). ON (B)(6) 2025, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 9.530 UI/ML (REACTIVE). PATIENT 4: ON (B)(6) 2025, THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). THE CMV IGM RESULT WAS 0.137 COI (NON-REACTIVE). ON (B)(6) 2025, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 11.590 UI/ML (REACTIVE). THE CMV IGM RESULTS FOR ALL OF THE PATIENTS WERE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993039 ↗
• MalfunctionApr 29, 2025False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ASSAY NOT MATCHING THE PATIENT'S CLINICAL EXPECTATION ON A COBAS E801 MODULE. INITIAL RESULT: 179 U/ML (REACTIVE). ON 27-MAR-2025, THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 176 U/ML (REACTIVE). CMV IGG AVIDITY RESULT: NEGATIVE (WHEN TESTED WITH LIAISON AT THE SAME FACILITY). RECOMLINEBLOT RESULT: NEGATIVE (WHEN TESTED IN ANOTHER FACILITY). VIRION-BLOT RESULT: BORDERLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926161 ↗
• MalfunctionApr 18, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED A NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM THE E801 ANALYZER WAS < 15 U/ML (NEGATIVE). THE RESULT FROM A COMPETITOR METHOD WAS 38 (POSITIVE). THE UNIT OF MEASURE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866320 ↗
• MalfunctionMar 31, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CMV IGG RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER REPORTED REPETITIVE NEGATIVE ELECSYS CMV IGG RESULTS, WITH AN INITIAL RESULT OF 0.478 U/ML ON (B)(6) 2025 AND REPEAT RESULTS OF 0.502 U/ML AND 0.603 U/ML ON (B)(6) 2025. THEY RECEIVED A POSITIVE CMV AVIDITY RESULT FROM AN EXTERNAL LAB OF 0.68 U/ML ON (B)(6) 2025. A RESULT FOR CMV IGM WAS PROVIDED AS 8.45 COI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729832 ↗
• MalfunctionMar 7, 2025False Positive Result; High Test Results; False Positive Result; High Test Results

  THE INITIAL REPORTER QUESTIONED A POSITIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 21 U/ML (POSITIVE). ACCORDING TO THE CUSTOMER¿S INTERNAL PROTOCOL, THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING AN E801 ANALYZER AND THE RESULT WAS 5 U/ML (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547964 ↗