HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Reported: February 5, 2025 Initiated: December 18, 2024 #Z-1020-2025
Product Description
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
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.
Details
- Recalling Firm
- Instrumentation Laboratory
- Units Affected
- 10,952 units (5,303 US, 5,649 OUS)
- 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.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic. Recalled by Instrumentation Laboratory. Units affected: 10,952 units (5,303 US, 5,649 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-1020-2025.
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