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Terminated

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.

FDA Recall Z-0807-2018 · Posted None

Recalling FirmOrtho Clinical Diagnostics Inc
Recall StatusTerminated
Product CodeJJY
Date Initiated2017-07-10
Date Terminated2020-08-06
Product Quantity10,021 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042006VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACEOrtho-Clinical Diagnostics, Inc. · 2004-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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