HemosIL LMW Heparin Controls; Part Number: 0020300200;
Reported: August 20, 2025 Initiated: February 3, 2025 #Z-2323-2025
Product Description
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Reason for Recall
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.
Details
- Recalling Firm
- Instrumentation Laboratory
- Units Affected
- 41,824 units
- Distribution
- 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.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
HemosIL LMW Heparin Controls; Part Number: 0020300200;. Recalled by Instrumentation Laboratory. Units affected: 41,824 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2323-2025.
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