Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

Recall date

December 18, 2024

Source

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

Recall number

Z-1020-2025

FDA classification

Class II

Brand / firm

Instrumentation Laboratory

Sold / distributed

Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iran (Islamic Repu…

Why it was recalled

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

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 Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic