cobas Babesia 08244049190Recalls & reported problems
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 00875197006131), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (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.
Reports received per month
Most reported problems
Device problems
- False Positive Result1
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.
MalfunctionSep 15, 2025False Positive Result; False Positive Result
THE INITIAL REPORTER ALLEGED AN INCREASE IN FALSE REACTIVE RESULTS WITH THE COBAS® BABESIA ASSAY ON THE COBAS 8800 ANALYZER. ON (B)(6) 2023, A POOLED SAMPLE OF SIX (PP6) GENERATED A REACTIVE RESULT FOR BABESIA. SUBSEQUENT TESTING OF THE SIX INDIVIDUAL SAMPLES (P1) FROM THE POOL GENERATED NON-REACTIVE RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058199 ↗
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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