HemosIL SynthAFax 00020007400Recalls & reported problems
Instrumentation Laboratory Company · HemosIL SynthAFax · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Nov 18, 2025Open, Classified
Recalled lots were manufactured with double the amount of preservative concentration.
Z-0938-2026 · Root cause: Process control · Recall details · FDA record ↗
Other ACTIVATED PARTIAL THROMBOPLASTIN devices
- HemosIL SynthASil 00020006800Instrumentation Laboratory Company · ACTIVATED PARTIAL THROMBOPLASTIN1 recall18 reports
- Dade® Actin® Activated Cephaloplastin Reagent 10445711Siemens Healthcare Diagnostics Products GmbH · ACTIVATED PARTIAL THROMBOPLASTIN12 reports
- Pathromtin® SL 10446066Siemens Healthcare Diagnostics Products GmbH · ACTIVATED PARTIAL THROMBOPLASTIN11 reports
- Pathromtin® SL 10446067Siemens Healthcare Diagnostics Products GmbH · ACTIVATED PARTIAL THROMBOPLASTIN3 reports
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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