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

Recalled February 5, 2025 · FDA recall Z-1020-2025 · Instrumentation Laboratory

Hazard

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. · FDA Class II

Units

10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)

Sold at

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 Republic of), Ireland, Israel, Italy, Japan, Korea (the Republic of), Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Mexico, Netherlands (the), Norway, Philippines (the), Poland, Portugal, Qatar, Romania, Russian Federation (the), Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan (Province of China), Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Description

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.

Product

HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

Manufacturer(s)

Instrumentation Laboratory

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →