Z-0673-2025 Class II Ongoing
FDA device recall Z-0673-2025 was initiated by Beckman Coulter Inc. on November 8, 2024 and is designated Class II. Reason for recall: The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact P… The recall status is ongoing. Affected quantity: 31 US; 167 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- November 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 US; 167 OUS
Product Description
Reason for Recall
Distribution Pattern
Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, Egypt, France, Germany, Ghana, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, S. Korea, Spain, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.