Tinaquant Myoglobin Gen2 4580010190Recalls & 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
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630921294), received between Aug 20, 2019 and Aug 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 other recall cover devices cleared under the same FDA submission (K061683); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Nonstandard Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2019Nonstandard Device; Incorrect, Inadequate or Imprecise Result or Readings
THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. QUESTIONABLE NON-REPRODUCIBLE MYO2 MYOGLOBIN GEN.2 RESULTS WERE GENERATED BY THE COBAS 6000 C501 MODULE AND THE COBAS 8000 C 502 MODULE. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS. THE PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' GENDERS WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT WERE NOT PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8909904 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061683. One submission often covers many models, so check the product and lot details in each record.
- Z-2445-2019 · Jul 2, 2019 · TerminatedThe Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated
Other MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL devices
- ARCHITECT 2K43-20Abbott Ireland Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 recall8 reports
- PATHFAST Myo-II N/APhc Corporation · Myoglobin, Antigen, Antiserum, Control1 recall0 reports
- Triage 97300EUQuidel Cardiovascular Inc. · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL8 reports
- VITROS 6801042Ortho Clinical Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL7 reports
- Alere Triage® 97000HSAlere San Diego, Inc. · Myoglobin, Antigen, Antiserum, Control6 reports
- Elecsys Myoglobin 07027583190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL6 reports
- Alinity 04V3720Abbott Ireland Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Tina-quant Myoglobin Gen.2 08252629190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 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.
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