Dimension Vista System - Gentamicin Assay, Dimension Clinical Chemistry System - Gentamicin, Dimension Xpand System - Genamicin (gent) Assay, Dimension Exl System Gentamicin (gent) Assay (2018-04-24
Recall Summary Siemens Healthineers is recalling gentamicin assay tests used in hospital laboratory systems (Dimension Vista, Clinical Chemistry, Xpand, and EXL models) across Canada due to a manufacturing issue with the medical devices. The affected tests are used to measure gentamicin antibiotic levels in patient blood samples. This recall applies to healthcare facilities and laboratories that use these Siemens systems.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-05-25
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3aa0c2b9-1d05-48d1-91ef-1b105cd60fdb