Vitros Eci Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & Ca (2018-08-31)

Recall Summary Ortho Clinical Diagnostics is recalling VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls and Calibrators distributed across Canada. The recall was issued because these medical devices do not meet required quality standards. This affects healthcare facilities and laboratories that use these products for vitamin B12 testing.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-09-17

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d088a986-677f-4f36-a3ba-a8f888c8d3d6