Unicel Dxi 600 Access Immunoassay System - Intrinsic Factor Ab (2019-04-13)
Recall Summary The UniCel DxI 600 Access Immunoassay System for Intrinsic Factor AB testing is being recalled across Canada. The device was recalled due to issues classified as a Class I medical device concern, which indicates a serious problem with the product. This recall affects medical laboratories and healthcare facilities in Canada that use this specific testing system.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-05-03
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4cbc3288-fc21-416d-9ac3-f640db92b43e