cobas e 801 Immunoassay analyzer 08459606001Recalls & reported problems
Roche Diagnostics GmbH · Class 1
All models of cobas e 801 Immunoassay analyzer (3)
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 07613336158562), received between Jul 16, 2021 and Jul 16, 2021 — 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.
MalfunctionJul 16, 2021Non Reproducible Results; Non Reproducible Results
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TOXO IGG (TOXO IGG) ON A COBAS E801 MODULE. THE INITIAL RESULT WAS 0.51 UI/ML (NEGATIVE). ON (B)(6) 2021 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 9.26 UI/ML (POSITIVE). ON (B)(6) 2021 THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 8.9 UI/ML (POSITIVE). THE NEGATIVE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE TOXO IGG REAGENT LOT NUMBER WAS 517479. THE EXPIRATION DATE WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12183238 ↗
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- ARCHITECT 3L77-01Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE2 recalls1 death694 reports
- ARCHITECT 3M74-02Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall650 reports
- ARCHITECT 2P24-40Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall1 death646 reports
- cobas e 411 Immunoassay Analyzer 04775201001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE685 reports
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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