HemosIL Heparin Calibrators recall
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Why was HemosIL Heparin Calibrators 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)
- 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.
- Recall date
- February 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)