Cobas Integra Tina-quant Ha1c Gen.2 And Cobas C 111 A1c-2 (2016-10-06)

Recall Summary Roche is recalling COBAS INTEGRA TINA-QUANT HA1C GEN.2 and COBAS C 111 A1C-2 blood testing devices across Canada due to a medical device issue. These devices are used to measure hemoglobin A1C levels, which help diagnose and monitor diabetes. The recall is classified as Class I, meaning there is a serious potential health risk associated with these devices.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-10-06

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1e6e894e-16a6-4a0c-9ee1-5b0d5bfcf35d