HemosIL LMW Heparin Controls 00020300200Recalls & reported problems
Instrumentation Laboratory Company · HemosIL LMW Heparin Controls · Class 2
Data updated Oct 18, 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 18, 2026.
Recalls naming this device
- Feb 3, 2025Class IIOpen, Classified
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Z-2323-2025 · Root cause: Process control · Recall details · FDA record ↗
Other ASSAY, HEPARIN devices
- STA® - Liquid Anti-Xa 8 00322USDiagnostica Stago · ASSAY, HEPARIN1 recall0 reports
- STA® - Liquid Anti-Xa 4 00311USDiagnostica Stago · ASSAY, HEPARIN1 recall0 reports
- Berichrom® Heparin 10446620Siemens Healthcare Diagnostics Products GmbH · ASSAY, HEPARIN7 reports
- INNOVANCE Heparin 10873535Siemens Healthcare Diagnostics Products GmbH · ASSAY, HEPARIN5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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