Elecsys CMV IgM 07027133190Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04015630940189), received between Oct 19, 2022 and Sep 3, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (19 reports).

2 other recalls cover devices cleared under the same FDA submission (K163569); 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026False Negative Result

  We received an allegation that the Elecsys CMV IgM assay results from the cobas e 801 analytical unit for one pregnant patient may not have detected an alleged primary cytomegalovirus (CMV) infection in the periconceptional period, and may have contributed to her newborn¿s alleged bilateral hearing loss.On (b)(6) 2025, at 6 weeks amenorrhea, the patient's Elecsys CMV IgM result was allegedly 0.819 COI (The IgM Roche-ratio interpretation was allegedly borderline > 0.70 to <1; positive > 1); the Elecsys CMV IgG result was allegedly 4.8 "UA/mL" (Positive). On (b)(6) 2026, at 9 weeks and 2 days amenorrhea, the patient's Elecsys CMV IgM result was allegedly 0.448 COI (Negative), and the Elecsys CMV IgG result was allegedly 18.3 COI (Positive). The results were allegedly concluded as long-standing immunity.In the second trimester of the patient's pregnancy, at around 20 to 24 weeks of amenorrhea, the ultrasound results allegedly showed abnormalities and severe intrauterine growth restriction, prompting further investigation via amniocentesis with genetic and infectious disease testing. The amniocentesis infectious disease workup allegedly revealed fetal CMV infection, and the CMV polymer

  Patient problems: Neonatal Hearing Impairment

  MAUDE report 50586693 ↗
• MalfunctionAug 27, 2026False Negative Result

  There was an allegation of questionable Elecsys CMV IgM results for one patient from the cobas e 801 module.Refer to the attachment to the Medwatch for all patient data.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472854 ↗
• MalfunctionAug 12, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224798 ↗
• InjuryJul 28, 2026False Negative Result

  We received an allegation about discrepant results for 2 samples from the same patient tested with Elecsys CMV IgM assay on a cobas e 801 analytical unit.The pregnant patient was tested using the Liaison method:On (b)(6)2025, the CMV IgM result was 63 UA/mL (Positive).On (b)(6)2025, the CMV IgM result was 61 UA/mL (Positive).It was alleged that on (b)(6)2025, the Elecsys CMV IgM result was 0.68 COI, and on (b)(6)2025, the Elecsys CMV IgM result was 0.69 COI, and both results were considered Non¿reactive.On (b)(6) 2025, the patient was tested using the Liaison method, and the CMV IgM result was 29 UA/mL (Positive).Allegedly, the baby was tested with urine CMV PCR, and the result was 7.34 IU/mL (Positive). Reportedly, it was alleged that the baby is receiving unspecified treatment and has hearing loss.This MDR is being submitted in an abundance of caution.

  Patient problems: Insufficient Information; Neonatal Hearing Impairment

  MAUDE report 50052864 ↗
• MalfunctionApr 24, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL SERUM SAMPLE RESULT WAS 1.71 COI (REACTIVE). THE SAMPLE WAS RECENTRIFUGED AND REPEATED AND THE RESULT WAS 1.67 COI (REACTIVE). A PLASMA SAMPLE COLLECTED AT THE SAME TIME WAS TESTED AND THE RESULT WAS 0.332 COI (NON-REACTIVE). ON EITHER 12-APR OR (B)(6) 2026, THE PLASMA SAMPLE WAS REPEATED AND THE RESULT WAS 0.626 COI (NON-REACTIVE). THE EXACT DATE OF TESTING WAS NOT PROVIDED. THE CUSTOMER DEEMED THE NON-REACTIVE RESULT AS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987409 ↗
• InjuryApr 22, 2026False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CMV IGM RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A DIASORIN ANALYZER. 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 (NEGATIVE) IU/ML AND THE CMV IGG RESULT WAS 3.43 IU/ML (POSITIVE). THE SAMPLE WAS REPEATED AGAIN ON

  Patient problems: Insufficient Information

  MAUDE report 24957496 ↗
• 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 IGM ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CMV IGG 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 23696220 ↗
• MalfunctionNov 21, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FOR 1 PATIENT SAMPLE ON AN UNKNOWN COBAS ANALYZER COMPARED TO A COMPETITOR ANALYZER. THE ROCHE RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED ON A VIDAS ANALYZER AND THE RESULT WAS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619401 ↗
• MalfunctionNov 14, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. ON (B)(6) 2025: ELECSYS CMV IGM RESULT WAS 0.58 COI (NON-REACTIVE). ELECSYS CMV IGG RESULT WAS 24.4 U/ML (REACTIVE). ON (B)(6) 2025: VIDAS CMV IGG RESULT WAS 25 AU/ML (REACTIVE). VIDAS CMV IGG AVIDITY RESULT WAS 40 AVI% (EQUIVOCAL). DIASORIN LIAISON CMV IGM RESULT WAS 32.7 AU/ML (REACTIVE). DIASORIN LIAISON CMV IGG RESULT WAS 69.8 AU/ML (REACTIVE) DIASORIN LIAISON CMV IGG AVIDITY RESULT WAS 0.199. ON (B)(6) 2025: ELECSYS CMV IGM RESULT WAS 0.54 COI (NON-REACTIVE). ELECSYS CMV IGG RESULT WAS 21.3 U/ML (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556199 ↗
• MalfunctionOct 15, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER COMPLAINED OF A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGM (CMV IGM) ON A COBAS E 402 ANALYTICAL UNIT. THE RESULT FROM THE E402 ANALYZER WAS 0.290 COI (NEGATIVE). THE RESULT FROM AN UNSPECIFIED ENZYME-LINKED FLUORESCENT ASSAY (ELFA) METHOD WAS "BORDERLINE." THE SPECIFIC RESULT WAS NOT PROVIDED. THE DNA BLOOD TEST RESULT WAS "NEGATIVE." THE URINE TEST WAS "POSITIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288013 ↗
• MalfunctionOct 15, 2025False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CMV IGM ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 0.337 COI AND INTERPRETED AS NON-REACTIVE. ON (B)(6) 2025: THE SAMPLE WAS TESTED, AND THE RESULT WAS 0.326 COI AND INTERPRETED AS NEGATIVE. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY USING THE CHEMILUMINESCENCE METHOD AND REPEATED. THE 1ST REPEAT RESULT WAS 56.1 AND INTERPRETED AS POSITIVE. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THIS RESULT WAS REPORTED. THE SAMPLE WAS THEN REPEATED USING THE ENZYME-LINKED FLUORESCENCE ASSAY (ELFA) METHOD ON A DIASORIN LIAISON INSTRUMENT, AND THE 2ND REPEAT RESULT WAS POSITIVE. ON (B)(6) 2025: THE SAMPLE WAS TESTED AFTER PERFORMING QC, AND THE RESULT WAS 0.316 COI AND INTERPRETED AS NON-REACTIVE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278151 ↗
• 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 IGM ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS CMV IGG 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 22326946 ↗
• MalfunctionMar 20, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 11 PATIENT SAMPLES TESTED FOR ELECSYS CMV IGM (CMV IGM) ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE RESULTS FOR ALL 11 PATIENT SAMPLES WERE "NEGATIVE" ON THE E402 ANALYZER. THE RESULTS FOR THE 11 PATIENT SAMPLES WERE EITHER "POSITIVE" OR INDETERMINATE BY THE COMPETITOR METHOD. NO ACTUAL RESULTS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652131 ↗
• MalfunctionOct 4, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG AND ELECSYS CMV IGM ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS CMV IGM ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CMV IGG ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370239 ↗
• MalfunctionSep 3, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGM RESULTS FROM THE COBAS E 801 MODULE. THE ROCHE IGM RESULT WAS 0.3 (NEGATIVE) REPEATEDLY. THE BIOMERIEUX IGM RESULT WAS 1.72 (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129424 ↗
• MalfunctionJul 23, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGM RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE PATIENT WAS EXPECTED TO BE CMV IGM POSITIVE BASED ON THE PREVIOUS RESULT FROM ANOTHER LABORATORY THAT USES A VIDAS ANALYZER ( ON (B)(6) 2024: 1.25 AU/ML - POSITIVE). ON (B)(6) 2024: THE RESULT FROM THE ANALYZER WAS 0.571 CUT-OFF INDEX COI (NEGATIVE/NON-REACTIVE). THE RESULT FROM THE VIDAS ANALYZER WAS 1.23 COI (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807365 ↗
• MalfunctionOct 23, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS CMV IGM ON A COBAS E 801 ANALYTICAL UNIT IN COMPARISON TO RESULTS MEASURED WITH A COMPETITOR METHOD. THE FIRST SAMPLE WAS TESTED WITH THE COMPETITOR METHOD ON (B)(6) 2023, RESULTING IN A CMV IGM VALUE OF 1.51 INDEX (REACTIVE). THE FIRST SAMPLE RESULTED IN A CMV IGM VALUE OF 0.568 COI (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2023. THE SECOND SAMPLE WAS TESTED WITH THE COMPETITOR METHOD ON (B)(6) 2023, RESULTING IN A CMV IGM VALUE OF 1.76 INDEX (REACTIVE). THE FIRST SAMPLE RESULTED IN A CMV IGM VALUE OF 0.221 COI (NON-REACTIVE) WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984384 ↗
• MalfunctionSep 14, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CMV IGM (CMV IGM) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER CONFIRMED THE INITIAL RESULT USING A MINI VIDAS ANALYZER. THE INITIAL RESULT FROM THE ANALYZER WAS 0.35 CUT-OFF INDEX COI (NEGATIVE). THE REPEAT RESULT FROM THE MINI VIDAS ANALYZER WAS 1.28 (POSITIVE). THE PATIENT IS SUSPECTED TO HAVE CYTOMEGALOVIRUS (CMV) INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744102 ↗
• MalfunctionJun 14, 2023False Negative Result; False Negative Result

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT NEGATIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) AND ELECSYS CMV IGM (CMV IGM) ON A COBAS E 801 MODULE. THIS MEDWATCH WILL COVER CMV IGM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6). FOR INFORMATION ON THE CMV IGG RESULTS. THE CMV IGM RESULT FROM THE E801 MODULE WAS 0.635 COI (NEGATIVE). THE CMV IGG RESULT FROM THE E801 MODULE WAS 0.408 U/ML (NEGATIVE). THE SAMPLE WAS REPEATED BY THE CHORUS METHOD AND THE RESULTS WERE POSITIVE. THE SPECIFIC RESULTS WERE NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 MODULE SERIAL NUMBER WAS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130598 ↗
• 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 IGM. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CMV IGG 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 (NEGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516443 ↗
• MalfunctionJan 6, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGM IMMUNOASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE DATA HIGHLIGHTED IN RED IS QUESTIONABLE AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT DID NOT AGREE WITH RESULTS OBTAINED WITH COMPETITOR METHODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117578 ↗
• MalfunctionOct 19, 2022False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE NEGATIVE CMV IGM ELECSYS RESULTS FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). FOR A SAMPLE COLLECTED ON (B)(6) 2022, THE RESULT WAS NEGATIVE. WHEN TESTED ON A VIDAS ANALYZER, THE RESULT WAS POSITIVE. FOR A SAMPLE COLLECTED ON (B)(6) 2022, THE RESULT WAS NEGATIVE. WHEN TESTED ON A VIDAS ANALYZER, THE RESULT WAS POSITIVE. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632292 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163569. One submission often covers many models, so check the product and lot details in each record.

• Z-1249-2019 · Mar 15, 2019 · Terminated
  cobas e 801 immunoassay analyzer
• Z-2136-2018 · Apr 3, 2018 · Terminated
  cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human bo