Z-0025-2025 Class II Ongoing
FDA device recall Z-0025-2025 was initiated by Beckman Coulter, Inc. on April 18, 2024 and is designated Class II. Reason for recall: When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expire… The recall status is ongoing. Affected quantity: 164 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- April 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164 units
Product Description
Reason for Recall
Distribution Pattern
Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.