X-cal, Sysmex E-check, 8check 3wp X-tra Control, Sysmex Scs-1000 Universal Calibrator, Xn Check, Xn Cal, Xn Cal Pf, Xn Cal - Customer Set, Xn Cal Pf - Customer Set, And Xn-l Check (2018-05-08)
Recall Summary Sysmex has recalled multiple laboratory control and calibration products used in blood testing equipment across Canada due to issues with these medical devices. The recalled products include various calibrators and controls used with Sysmex analyzers (E-Check, 8Check 3WP X-TRA Control, SCS-1000 Universal Calibrator, and XN-series products). This is a Class I recall, the most serious type, affecting healthcare facilities and laboratories that use these Sysmex devices nationwide.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-08-17
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a0918ec7-f94f-47f9-8936-e4d47982eff6