ONLINE TDM Acetaminophen Gen2 6769942190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630935031), received between Dec 21, 2022 and Dec 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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 Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ACETAMINOPHEN GEN.2 ASSAY ON A COBAS 6000 C 501 (UL) V MODULE. INITIAL RESULT: 196.0 G/ML. THE CUSTOMER NOTICED A QC SHIFT. AFTER THE CALIBRATION AND QC WERE PERFORMED AGAIN, THE SAMPLE WAS REPEATED. REPEAT RESULT: 278.2 G/ML. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758941 ↗MalfunctionDec 21, 2022Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ACET2 (ONLINE TDM ACETAMINOPHEN GEN.2) ASSAY ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN AN ACET2 VALUE OF 35.6 UMOL/L AND REPEATED AS 501.6 UMOL/L THE FOLLOWING DAY. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE ACET2 REAGENT LOT WAS 59848101 WITH AN EXPIRATION DATE OF 30-APR-2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16023876 ↗
Other COLORIMETRY, ACETAMINOPHEN devices
- Atellica CH Acet 11097522Siemens Healthcare Diagnostics Inc. · COLORIMETRY, ACETAMINOPHEN3 reports
- Dimension Vista® Flex® reagent cartridge ACTM 10445110Siemens Healthcare Diagnostics Inc. · COLORIMETRY, ACETAMINOPHEN2 reports
- ONLINE TDM Acetaminophen Gen.2 08056684190Roche Diagnostics GmbH · COLORIMETRY, ACETAMINOPHEN2 reports
- VITROS 1037274Ortho-Clinical Diagnostics, Inc. · COLORIMETRY, ACETAMINOPHEN1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page