Immage Immunochemistry Systems Kappa Light Chain (kap) (2017-11-03)

Recall Summary The IMMAGE Immunochemistry Systems Kappa Light Chain (KAP) device is being recalled across Canada due to a medical device issue. This device is used in laboratory testing to measure kappa light chain proteins in patient samples. The recall is classified as Class I, which indicates a serious safety concern.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-12-08

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/29cb9fbd-f110-422c-8ec8-78eacfcd6e6c