cobas® HBV 09040820190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00875197006414), received between Aug 30, 2023 and Nov 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT WITH THE COBAS® HBV (192T) ASSAY FOR A PATIENT SAMPLE TESTED ON THE COBAS 5800 ANALYZER. ON (B)(6) 2025, THE INITIAL RESULT WAS TARGET NOT DETECTED. THE SAMPLE WAS REPEATED USING A COMPETITOR METHOD (ALINITY M) AND THE RESULT WAS 3.69 LOG (4897.79). ON (B)(6) 2025, THE SAMPLE WAS REPEATED TWICE ON THE COBAS 5800 AND THE RESULTS WERE 3.29 LOG (1949.84) AND 3.20 LOG (1584.89), RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556197 ↗
• MalfunctionOct 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® HBV (192T) RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS 6800 ANALYZER. ON (B)(6) 2025: THE INITIAL RESULT WAS 16700 IU/ML. ON (B)(6) 2025: THE REPEAT RESULT ON THE SAME ANALYZER WAS TARGET NOT DETECTED. ON (B)(6) 2025: THE REPEAT RESULT ON A SECOND COBAS 6800 ANALYZER WAS <TITER MIN. THE INITIAL RESULT WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438079 ↗
• MalfunctionDec 11, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS WITH THE COBAS HBV QUANTITATIVE ASSAY FOR ONE PATIENT ON THE COBAS 6800 ANALYZER COMPARED TO AN IN-HOUSE METHOD AT A REFERENCE LABORATORY. 3 SEPARATE SAMPLES FROM THE SAME PATIENT WERE TAKEN AND THE FOLLOWING RESULTS WERE GENERATED: THE INITIAL RESULT WAS 642 IU/ML WITH A SERUM SAMPLE. A 1:2 DILUTION WAS PERFORMED AND THE RESULT WAS 321 IU/ML. THE SAMPLE WAS REPEATED WITH AN IN-HOUSE METHOD AND THE RESULT WAS 10,000 IU/ML. ON (B)(6) 2024, THE INITIAL RESULT WAS 689 IU/ML WITH A PLASMA SAMPLE AND THE REPEATED RESULT WITH AN IN-HOUSE METHOD WAS 10,000 IU/ML. A SERUM SAMPLE WAS ALSO TESTED AT ANOTHER LABORATORY, GENERATING A 548 IU/ML WITH THE COBAS 6800. ON (B)(6) 2024, THE INITIAL RESULT WAS 5,260 IU/ML WITH A PLASMA SAMPLE AND THE REPEATED RESULT WITH AN IN-HOUSE METHOD WAS 170,000 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901321 ↗
• MalfunctionNov 7, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR A SINGLE PATIENT USING THE COBAS® HBV QUANTITATIVE NUCLEIC ACID TEST FOR USE ON THE COBAS® 5800/6800/8800 SYSTEMS. ON (B)(6)2024, THE ALLEGED SAMPLE WAS TESTED ON A COMPETITOR'S ASSAY (SANSURE PLATFORM), GENERATING A POSITIVE RESULT OF 1.39E+4 IU/ML AND 8.8E+3IU/ML, RESPECTIVELY. ON (B)(6) 2024, THE SAME SAMPLE WAS REPEATED THREE TIMES ON THE COBAS 6800 SYSTEM, GENERATING A TARGET NOT DETECTED (NEGATIVE) RESULT EACH TIME. ACCORDING TO THE SEQUENCING RESULTS PROVIDED BY THE CUSTOMER, SANSURE SHOWED THAT IT WAS HBV C SUBTYPE. ON (B)(6) 2024, THE SAMPLE WAS TESTED ON ANOTHER PLATFORM (HBV DNA QUANTITATIVE DETECTION BY DAAN GENE) WHICH WAS NEGATIVE. AS THE ONLY POSITIVE RESULTS WERE GENERATED WITH THE SANSURE ASSAY, THE CUSTOMER COMBINED THE PATIENT'S CLINICAL PRESENTATION, SEROLOGICAL RESULTS, AND THE HBV DNA TEST RESULTS FROM MULTIPLE MANUFACTURERS AND RELEASED THE SAMPLE AS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635151 ↗
• MalfunctionAug 30, 2023Non Reproducible Results; Non Reproducible Results

  A CUSTOMER FROM JAPAN ALLEGED DISCREPANT RESULTS FOR A SINGLE PATIENT WHEN USING THE COBAS HBV QUANTITATIVE ASSAY FOR USE ON THE COBAS 58/68/8800 SYSTEMS. THE ALLEGED SAMPLE INITIALLY GENERATED TITER MAX RESULT ON (B)(6) 2023. ON (B)(6) 2023, THE SAME SAMPLE WAS RETESTED AND GENERATED AN INVALID RESULT. ON (B)(6) 2023, THE SAME SAMPLE WAS RETESTED AND GENERATED A TARGET NOT DETECTED (TND) RESULT. A COMPETITOR SEROLOGY TEST (DETAILS UNKNOWN) FOR HEPATITIS B CORE ANTIGEN WAS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653412 ↗