VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on…

Date

March 7, 2018

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Ortho Clinical Diagnostics Inc

Product

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.

Reason

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.

Distribution pattern

Worldwide

Quantity

10,021 units

Codes and lots

Lot K4852, Expiration 22 Feb 2018

Recall started

July 10, 2017

Device type

Multi-Analyte Controls, All Kinds (Assayed)

Root cause (FDA)

Unknown/Undetermined by firm

What the company told customers

On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.

Recall number

Z-0807-2018

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0807-2018. The agency record governs; check it and the company before acting.