FDA Medical devices recall ·
HemosIL Heparin Calibrators recall
- Recall number
- Z-1020-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Instrumentation Laboratory
180 Hartwell Rd, Bedford, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673; ****Lot numbers added 4/15/2026**** N0531891, N0733658, N0249207, N0442161, N0744673, N1147734, N020463, N0250464, N0452277, N0553155, N0754506;
Distribution
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.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1020-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.