Z-1020-2025 Class II Ongoing
FDA device recall Z-1020-2025 was initiated by Instrumentation Laboratory on December 18, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026).
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2025
- Initiation Date
- December 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)
Product Description
Reason for Recall
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.