cobas pro SBL e 801 09211888001Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 16, 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 07613336179918), received between Jul 29, 2022 and Jul 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test 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 16, 2026.
Most reported problems
Device problems
- Low Test 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 29, 2022Low Test Results; Low Test Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 ASSAY, PROBNP G2 ELECSYS E2G V2, ELECSYS FERRITIN, FOLATE, ELECSYS TSH ASSAY AND ELECSYS VITAMIN B12 IMMUNOASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS PRO SBL E 801. FOR SAMPLE 2063033611, THE INITIAL FT4 RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN DID NOT BELIEVE THE RESULT PROMPTING THE RERUN OF SEVERAL ASSAYS. DISCREPANT RESULTS WERE OBSERVED FOR FT4 AND PROBNP. ON (B)(6) 2022, SAMPLE 1'S INITIAL FT4 RESULT WAS 1.820 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 40.9 PMOL/L. THE INITIAL PROBNP RESULT WAS <1 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 67 PMOL/L. ON (B)(6) 2022, SAMPLE 2071221711'S INITIAL FERRITIN RESULT WAS 1.640 UG/L WITH A DATA FLAG. THE REPEAT RESULT WAS 114 UG/L. THE INITIAL FOLATE RESULT WAS <2.72 NMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 45.100 NMOL/L. THE INITIAL TSH RESULT WAS <0.1 MIU/L WITH A DATA FLAG. THE REPEAT RESULT WAS 5.000 MIU/L. THE INITIAL VITAMIN B12 RESULT WAS <73.8 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 366 PMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE FT4 REAGENT LOT NUMBER IS 60647801 WITH AN EXPIRATION DATE OF 30-NOV-2022. THE PROBNP REAG
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15133328 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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