COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0Recalls & reported problems
Roche Molecular Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00875197002706), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (1 report).
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
Device problems
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2022Non Reproducible Results; Non Reproducible Results
A CUSTOMER IN CHINA ALLEGED DISCREPANT RESULTS FOR ONE PATIENT WHILE USING THE COBAS® AMPLIPREP AND COBAS® TAQMAN® HBV TEST, V2 (CAP/CTM HBV V2). THE ALLEGED SAMPLE INITIALLY A GENERATED POSITIVE RESULT WITH A TITER OF 15,800 IU/ML WITH A COMPETITOR PLATFORM. A REPEAT OF THE SAMPLE ON THAT SYSTEM GAVE CONSISTENT RESULTS. A NEW BLOOD DRAW WAS TAKEN AND TESTED ON THE CAP/CTM HBV V2 ASSAY AND GAVE A RESULT OF TARGET NOT DETECTED (TND). THEN, THE ORIGINAL AND THE NEW COLLECTED SAMPLES WERE RETESTED ON CAP/CTM HBV V2 ASSAY AND BOTH GAVE RESULTS OF TND. THE NEW COLLECTED SAMPLE WAS ALSO RETESTED ON THE COMPETITOR PLATFORM AND PRODUCED A POSITIVE RESULT OF 2,230 IU/ML. THE POSITIVE AND NEGATIVE RESULTS WERE RELEASED. NO HARM IS ALLEGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15321268 ↗
Other Hepatitis Viral B DNA Detection devices
- cobas® HBV 09040820190Roche Molecular Systems, Inc. · Hepatitis Viral B DNA Detection5 reports
- Alinity m 08N47-095Abbott Molecular Inc. · Hepatitis Viral B DNA Detection1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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