FDA-Device2025-08-20Class II
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Instrumentation Laboratory
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.
Sold states
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.
Affected count
41,824 units
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Products
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2025Don't want to check this manually?
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