Immage Immunochemistry System Total Immunoglobulin E (ige) Reagent And Cal (2019-09-04)

Recall Summary The IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Calibrator have been recalled in Canada due to safety concerns with the medical device. This product is used in laboratories to measure immunoglobulin E levels in patient blood samples. The recall affects all units distributed across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-10-03

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9ad4cab3-a45f-4ff5-aa2e-10cc5fa80121