Hitachi Hico Creatinine Jaffe Method, Crej2 Cobas (c 111, C 701/702, C 311/501/502), Ocbas Integra 400 Plus (2019-01-16)

Recall Summary Hitachi HICO Creatinine Jaffe Method testing kits and related equipment (CREJ2 cobas systems and OCBAS INTEGRA 400 plus) are being recalled across Canada. The recall is classified as Class I, indicating a serious issue with the medical device. The specific reason for the recall relates to the device's functionality, though further details on the exact problem are not provided in this notice.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-03-01

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/43f22624-022d-4046-a3d0-a2a6f96ec12c