I-stat Alinity Instrument With Analyzer Software (2017-12-21)

Recall Summary The i-STAT Alinity Instrument with Analyzer Software is being recalled across Canada because of a problem with the medical device itself. This recall affects all users of this instrument in Canada and is classified as a Class I recall, meaning the device poses a serious risk. The device is used in medical testing and analysis.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-01-29

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4899eb20-70d5-4d70-a8c3-04ff04e386c5