Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/3…

Recall date

July 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0807-2018

FDA classification

Class III

Brand / firm

Ortho Clinical Diagnostics Inc

Sold / distributed

Worldwide

Why it was recalled

VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.