cobas b 221 <2> system 3337111001Recalls & reported problems
Roche Diagnostics GmbH · 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630018307), received between Aug 30, 2021 and Aug 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Feb 22, 2018Class IITerminated
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Z-1610-2018 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Deformation1
- Suction Problem1
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, 2021Suction Problem; Material Deformation; Suction Problem; Material Deformation
THE INITIAL REPORTER COMPLAINED OF AUTO QC (AQC) ERRORS ON A COBAS B221 SYSTEM. THE CUSTOMER OPENED THE AQC DRAWER AND OBSERVED THAT THE MOTOR WAS NOT IN THE CORRECT POSITION AND WOULD NOT MOVE WHEN PROGRAMMED TO MOVE. THE QC MECHANISM WAS STUCK AND WOULD NOT RELEASE. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND A BURNT TUBE. NO ONE WAS INJURED BY THE BURNT TUBE AND NO QUESTIONABLE RESULTS WERE GENERATED DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12382784 ↗
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- EPOC BGEM CREA TEST CARD CT-1006-00-00Epocal Inc · Electrode, Ion Specific, Potassium2 recalls1 death1 report
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- EPOC READER HR-1002-00-00Epocal Inc · Electrode, Ion Specific, Potassium11 deaths88 reports
- cobas b 221 <4> system 3337138001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, POTASSIUM1 recall7 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 · each recall links to the FDA recall notice
- 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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