cobas b 221 GLU/LAC Cassette 03260887184Recalls & reported problems
Roche Diagnostics GmbH · Class 1
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 04015630018130), received between Aug 15, 2025 and Aug 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
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 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE LACTATE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE COBAS B 221 GLU/LAC CASSETTE ON A COBAS B 221 6 ROCHE OMNI S6 SYSTEM. THE CUSTOMER STATED THAT CONTROLS WERE 10 POINTS DIFFERENT ON THE COBAS B 221 SYSTEM COMPARED TO A SECOND COBAS B 221 ANALYZER. THE PATIENT SAMPLE WAS PROCESSED ON BOTH ANALYZERS IN PARALLEL. THE RESULT FROM THE SECOND COBAS B 221 SYSTEM WAS DEEMED CORRECT. THE SAMPLE RESULTED IN A LACTATE VALUE OF 15.8 WHEN TESTED ON THE COMPLAINED COBAS B 221 SYSTEM. WHEN TESTED ON THE SECOND SYSTEM, THE RESULT WAS 23.00 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815979 ↗
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- Atellica CH Lactate_2 (Lac_2) 11532568Siemens Healthcare Diagnostics Inc. · ACID, LACTIC, ENZYMATIC METHOD6 reports
- Lactate Gen.2 3183700190Roche Diagnostics GmbH · ACID, LACTIC, ENZYMATIC METHOD5 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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