Cobas Integra 400 Plus Analyzer, Cobas C 111 Stand Alone Configuration And Cobas C 111 With Ise Stand Alone Configuration (2018-12-10)
Recall Summary Roche is recalling three laboratory analyzer models (COBAS INTEGRA 400 plus, COBAS C 111 Stand Alone, and COBAS C 111 with ISE Stand Alone) distributed across Canada. These devices are recalled as Class I medical devices, indicating a serious issue with the product. The recall affects clinical laboratories and healthcare facilities that use these analyzers for patient testing.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-01-09
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/956592bb-225e-475d-acdf-f42f8ae7e187