cobas&#x00AE MPX (480 tests) 06998917190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00875197004779), received between Sep 16, 2025 and Sep 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS B VIRUS (HBV) WHEN USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 8800 INSTRUMENT. ON (B)(6) 2022, TWO ALIQUOTS WERE TAKEN FROM THE SAME DONOR SAMPLE. ONE ALIQUOT GENERATED A REACTIVE RESULT FOR HBV WITH A CYCLE THRESHOLD (CT) VALUE OF 36.8, WHILE THE OTHER ALIQUOT GENERATED A NON-REACTIVE RESULT. SEROLOGY TESTING FOR THE SAMPLE WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100144 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED A DISCREPANT RESULT WITH THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 8800 INSTRUMENT. THE ALLEGATION INVOLVED A SAMPLE (ID 9908345) THAT WAS REACTIVE FOR HEPATITIS B VIRUS (HBV) USING THE COBAS MPX ASSAY WITH A CYCLE THRESHOLD (CT) VALUE OF 35.6. THE AMPLIFICATION CURVE FOR THE HBV RESULT WAS DESCRIBED AS SIGMOIDAL AND ROBUST. HOWEVER, THE CORRESPONDING SEROLOGY RESULT FOR THE SAME SAMPLE WAS NEGATIVE, LEADING THE CUSTOMER TO CLASSIFY THE RESULT AS DISCREPANT. THE SAMPLE WAS PART OF A RUN BATCH (5302) THAT INCLUDED 35 SAMPLES AND 4 RUN CONTROLS. NO OTHER HBV-REACTIVE SAMPLES WERE PRESENT ON THE SAME PLATE, EXCEPT FOR ONE HIV-REACTIVE SAMPLE (ID 9908337). ALL RUN CONTROLS WERE VALID AND SHOWED EXPECTED RESULTS. BLOOD WAS NOT REPORTED TO HAVE BEEN RELEASED, AND NO HARM WAS ALLEGED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100139 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A QUESTIONABLE RESULT WITH THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. A PLASMA SAMPLE INITIALLY GENERATED A REACTIVE HIV RESULT WITH A NON-SIGMOIDAL CURVE AND A LATE CYCLE THRESHOLD (CT) VALUE OF 36.75. UPON RETESTING, THE SAMPLE WAS MISTAKENLY PROCESSED AS A SERUM SAMPLE, AND THE RESULT WAS NON-REACTIVE. NO ADDITIONAL TESTING RESULTS, SUCH AS SEROLOGY, WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099976 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED UNEXPECTED REACTIVE RESULTS USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER QUESTIONED SEVEN REACTIVE RESULTS SINCE (B)(6) 2020, ALL WITH LATE CYCLE THRESHOLD (CT) VALUES GREATER THAN 37. UPON RETESTING, ALL SEVEN SAMPLES GENERATED NON-REACTIVE RESULTS. SEROLOGY RESULTS FOR THE ALLEGED SAMPLES WERE REQUESTED BUT WERE NOT AVAILABLE. THE QUESTIONED RESULTS INCLUDED FOUR ALLEGED FALSE POSITIVE HIV RESULTS, ONE ALLEGED FALSE POSITIVE HEPATITIS B VIRUS (HBV) RESULT, AND TWO ALLEGED FALSE POSITIVE HEPATITIS C VIRUS (HCV) RESULTS. THE SPECIFIC SAMPLES WERE AS FOLLOWS: (B)(6) FOR HIV; (B)(6) FOR HBV; AND (B)(6) FOR HCV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099959 ↗
• MalfunctionSep 19, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS B VIRUS (HBV) USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 8800 INSTRUMENT. THE CUSTOMER REPORTED FOUR REACTIVE HBV RESULTS FROM POOLED SAMPLES TESTED ON (B)(6) 2021. THE INDIVIDUAL SAMPLES FROM THESE POOLS WERE IDENTIFIED AS FOLLOWS: (B)(6) (REACTIVE WITH A CYCLE THRESHOLD (CT) VALUE OF 37.3), (B)(6) (REACTIVE WITH A CT VALUE OF 36.1), (B)(6)(REACTIVE WITH A CT VALUE OF 37.5), AND (B)(6) (REACTIVE WITH A CT VALUE OF 37.9). SEROLOGY TESTING FOR THESE SAMPLES WAS NON-REACTIVE. THE SAMPLES WERE SENT TO A THIRD-PARTY LABORATORY FOR CONFIRMATORY TESTING USING A COMPETITOR ASSAY (GRIFOLS), WHICH ALSO YIELDED NON-REACTIVE RESULTS. THE DONATIONS WERE BLOOD AND WERE NOT RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098326 ↗
• MalfunctionSep 18, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED AN INCREASE IN THE RATE OF INITIALLY REACTIVE POOLS WHEN USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 8800 ANALYZER. THE CUSTOMER REPORTED OBSERVING AN INITIAL REACTIVE POOL RATE OF (B)(4), WHICH THEY COMPARED TO THE EXPECTED FALSE REACTIVE POOL RATE OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088577 ↗
• MalfunctionSep 17, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS B VIRUS (HBV) TESTING USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 8800 INSTRUMENT IN COMPARISON TO THE GRIFOLS PROCLEIX ULTRIO ASSAY. ON (B)(6) 2020, A SAMPLE FROM THE PATIENT WAS TESTED WITH THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY AND WAS REACTIVE FOR HBV. THE SAME SAMPLE WAS TESTED WITH THE PROCLEIX ULTRIO ASSAY AND WAS NON-REACTIVE FOR ALL TARGETS. SEROLOGY RESULTS FOR THE SAMPLE WERE NON-REACTIVE. ON (B)(6) 2020, ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED WITH THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY AND WAS REACTIVE FOR HBV. THE SAME SAMPLE WAS TESTED WITH THE PROCLEIX ULTRIO ASSAY AND WAS NON-REACTIVE FOR ALL TARGETS. SEROLOGY RESULTS FOR THE SAMPLE WERE ALSO NON-REACTIVE. THE BLOOD DONATION WAS DEFERRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073468 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED UNEXPECTED REACTIVE RESULTS FOR HEPATITIS B VIRUS (HBV) USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ON THE COBAS 8800 INSTRUMENT. THE ALLEGATION INVOLVES THREE SAMPLES FROM LONG-TIME NON-REACTIVE DONORS TESTED ON (B)(6) 2020. THE SAMPLES WERE IDENTIFIED AS (B)(6), WHICH GENERATED REACTIVE RESULTS FOR HBV WITH CYCLE THRESHOLD (CT) VALUES OF 38.4, 38.31, AND 38.47, RESPECTIVELY. SAMPLES FROM THE SAME DRAW OF EACH DONOR, BUT FROM DIFFERENT TUBES, WERE TESTED AS NON-REACTIVE FOR HBV. ADDITIONAL TESTING USING A COMPETITOR NUCLEIC ACID TESTING (NAT) ASSAY (GRIFOLS) AND SEROLOGY FOR ALL THREE DONORS WERE NON-REACTIVE. THE DONATIONS WERE NOT RELEASED. TWO ADDITIONAL SAMPLES TESTED ON THE SAME DATE, IDENTIFIED AS (B)(6), ALSO GENERATED REACTIVE RESULTS FOR HBV WITH CT VALUES OF 6.39 AND 6.25, RESPECTIVELY. HOWEVER, NO ALLEGATION WAS MADE REGARDING THESE TWO SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064145 ↗
• MalfunctionSep 16, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS C VIRUS (HCV) USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY. ON (B)(6) 2021, THE CUSTOMER TESTED A THIRD-PARTY PROFICIENCY PANEL. THREE SAMPLES (SAMPLES (B)(6) WERE NON-REACTIVE FOR HCV, WHEREAS THE EXPECTED RESULTS WERE REACTIVE. SAMPLE (B)(6) AND SAMPLE (B)(6) WERE DILUTED FROM A STOCK SOLUTION CONTAINING AN HCV VIRAL CONCENTRATION OF 500 IU/ML TO A SECONDARY STOCK SOLUTION OF 100 IU/ML. SAMPLE (B)(6) WAS DERIVED FROM THE SECONDARY STOCK SOLUTION OF 100 IU/ML AND WAS FURTHER DILUTED TO 25 IU/ML. ADDITIONALLY, SAMPLE (B)(6) WAS REACTIVE FOR HCV WITH A CYCLE THRESHOLD (CT) VALUE OF 36.5, BUT THE EXPECTED RESULT WAS NON-REACTIVE. IT WAS STATED THAT SAMPLE 5 CONTAINED NEGATIVE PLASMA. THE SAMPLES WERE PROVIDED TO THE CUSTOMER PRE-DILUTED AND READY FOR TESTING, WITH NO ADDITIONAL WORKFLOW REQUIRED. THE SAMPLES WERE STORED AS INDICATED IN THE INSTRUCTIONS AND WERE SHIPPED ON ICE. NO REMAINING SAMPLE WAS AVAILABLE FOR REPEAT TESTING, AND NO ADDITIONAL SAMPLES WERE REQUESTED FOR FURTHER TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062494 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED NINE DISCREPANT HIV RESULTS WHEN USING THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY ON THE COBAS 8800 INSTRUMENT. SPECIFICALLY, THE CUSTOMER REPORTED AN INCREASE IN INITIALLY REACTIVE POOLS, WHICH, UPON RESOLUTION TESTING, WERE ALL NON-REACTIVE. THE POOLS IN QUESTION WERE COMPOSED OF SIX SAMPLES EACH AND WERE TESTED AS PART OF BLOOD DONATION SCREENING. SEROLOGY RESULTS FOR THE SAMPLES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062491 ↗