Immunoglobulin M, A & G For Use On Cobas Integra 400/400 Plus/800 Analyzers & Ceru (ceruloplasmin) (2020-04-03)

Recall Summary Immunoglobulin M, A & G test kits and Ceruloplasmin test kits used with COBAS INTEGRA laboratory analyzers are being recalled across Canada due to a medical device issue. The recall affects healthcare facilities and laboratories that use these test kits with the specified COBAS analyzer models. This is classified as a Class I recall, which is the most serious category.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-05-08

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6b970d6a-584e-4a0d-ba4c-99af3f962c0d