cobas u pack 06334601001Recalls & 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 04015630932252), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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.
Reports received per month
Recalls naming this device
- Oct 18, 2021Class IITerminated
A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.
Z-0266-2022 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- False Negative 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.
MalfunctionAug 27, 2025False Negative Result; False Negative Result
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE NEGATIVE LEUKOCYTE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH A COBAS U PACK ON A COBAS U 601 URINE ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER RESULTS DID NOT MATCH THE CLINICAL DIAGNOSES OF THE PATIENTS. THE PATIENTS DID NOT HAVE ANY DISEASE. THE FIRST SAMPLE RESULTED IN A NEGATIVE LEUKOCYTE VALUE ON THE U 601 ANALYZER AND WHEN CHECKED ON A URINE MICROSCOPY ANALYZER, THE RESULT WAS 112.20 LEUKOCYTES/UL. THE SAMPLE WAS ALSO TESTED ON A SECOND URINE ANALYZER (COBAS U 411) AND THE LEUKOCYTE RESULT WAS 1+. A MANUAL MICROSCOPY READ OF THE URINE SAMPLE SHOWED MANY LEUKOCYTES (A SPECIFIC VALUE COULD NOT BE PROVIDED). THE SECOND SAMPLE RESULTED IN A NEGATIVE LEUKOCYTE VALUE WHEN TESTED ON THE U 601 ANALYZER ON (B)(6) 2025. WHEN CHECKED ON THE URINE MICROSCOPY ANALYZER ON (B)(6) 2025, THE RESULT WAS 87.12 LEUKOCYTES/UL. THE SAMPLE WAS TESTED ON THE SECOND URINE ANALYZER ON (B)(6) 2025, RESULTING IN A 1+ LEUKOCYTE RESULT. A MANUAL MICROSCOPY READ OF THE URINE SAMPLE SHOWED MANY LEUKOCYTES (A SPECIFIC VALUE COULD NOT BE PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902703 ↗
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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 · 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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