PATHFAST Myo-II N/ARecalls & reported problems
Phc Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 16, 2026.
Recalls naming this device
- Apr 30, 2018Class IITerminated
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.
Z-3185-2018 · Root cause: Process control · Recall details · FDA record ↗
Other Myoglobin, Antigen, Antiserum, Control devices
- ARCHITECT 2K43-20Abbott Ireland Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 recall8 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
- Tina-quant Myoglobin Gen.2 08252629190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Tinaquant Myoglobin Gen2 4580010190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Alinity 04V3720Abbott Ireland Diagnostics · 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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