Unicel Dxi 600, 800 Access Immunoassay System - Thyroglobulin Antibody II (2019-02-09)
Recall Summary Beckman Coulter is recalling UniCel DxI 600 and 800 Access Immunoassay Systems used to test for thyroglobulin antibodies due to a device issue. The recall affects systems distributed across Canada. This is a Class I recall, meaning there is a serious potential health risk associated with the device.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-03-08
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/206a6eb8-d8e1-46a6-8d34-3f6d8f776df3