Unicel Dxi 800 Access Immunoassay System
Recall Summary The UniCel DxI 800 Access Immunoassay System, a laboratory diagnostic device used to run blood tests, is being recalled across Canada due to an increased risk of adverse events. This Class I recall means the device could cause serious harm or death. The recall affects healthcare facilities and laboratories that use this system.
- Product
- UniCel DxI 800 Access Immunoassay System
- Reason
- Increased risk or new adverse events
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2021-10-29
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f42ed446-a9ee-4026-a8cf-e86d5d2545df