Instrumentation Laboratory: Device Recall

Recall #Z-1020-2025 · 12/18/2024

Class II: Risk

Recall Details

Recall Number: Z-1020-2025
Classification: Class II
Product Type: Device
Recalling Firm: Instrumentation Laboratory
Status: Ongoing
Date Initiated: 12/18/2024
Location: Bedford, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,952 units (5,303 US, 5,649 OUS)

Reason for Recall

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 Description

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

Distribution Pattern

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.

Other Recalls by Instrumentation Laboratory

Class II: Risk 12/11/2025

Potential for microbial contamination.
Class III: Low Risk 11/18/2025

Recalled lots were manufactured with double the amount of preservative concentration.
Class II: Risk 02/03/2025

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.

View all recalls by Instrumentation Laboratory →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.