HemosIL LMW Heparin Controls; Part Number: 0020300200;

Reason: 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.

Code information: Part Number: 0020300200; UDI-DI: 08426950472490; Lot Numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397;

Distribution pattern: 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.