Instrumentation Laboratory: Device Recall

Recall #Z-2323-2025 · 02/03/2025

Class II: Risk

Recall Details

Recall Number
Z-2323-2025
Classification
Class II
Product Type
Device
Recalling Firm
Instrumentation Laboratory
Status
Ongoing
Date Initiated
02/03/2025
Location
Bedford, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41,824 units

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.

Product Description

HemosIL LMW Heparin Controls; Part Number: 0020300200;

Distribution Pattern

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, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Vietnam.

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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.