Instrumentation Laboratory: Medical Device Recall in 2025 - (Recall #: Z-1020-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 18, 2024

Date Posted: February 5, 2025

Recall Number: Z-1020-2025

Event ID: 96044

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.

Status: Ongoing

Product Quantity: 10,952 units (5,303 US, 5,649 OUS)

Code Information:

Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673;

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.

Voluntary or Mandated:

Voluntary: Firm initiated