Reported Aug 20, 2025 · Ongoing
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Instrumentation Laboratory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- HemosIL LMW Heparin Controls
- Part Number0020300200
- Lot codes and dates
- Part Number0020300200
- UDI-DI08426950472490
- Lot Numbers
N0330228N0632773N0935135N1036592N0148986N0441476N0643673N0845161N1147397
- Amount recalled
- 41,824 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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