Instrumentation Laboratory: HemosIL LMW Heparin Controls; Part Number: 0020300200;

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.

Details from the source

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. 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 Quantity: 41,824 units Lot/code info: Part Number: 0020300200; UDI-DI: 08426950472490; Lot Numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397;

UPC codes

08426950472490

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.