FDAFDA · Food and drugs·Recall number Z-2323-2025
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Published August 20, 2025 · Recall initiated: February 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumentation Laboratory
- Distributor
- Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Macao, Malaysia, Mexico, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Vietnam.
- Lot
- Part Number: 0020300200; UDI-DI: 08426950472490; Lot Numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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