Z-1112-2025 Class II Ongoing
FDA device recall Z-1112-2025 was initiated by Beckman Coulter Inc. on January 2, 2025 and is designated Class II. Reason for recall: Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due … The recall status is ongoing. Affected quantity: 6,994 US; 10,067 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- January 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,994 US; 10,067 OUS
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam.