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

Recall date

February 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2323-2025

FDA classification

Class II

Brand / firm

Instrumentation Laboratory

Sold / distributed

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,…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HemosIL LMW Heparin Controls; Part Number: 0020300200;