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Terminated

VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626

FDA Recall Z-0173-06 · Posted 2005-11-18

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeLEH
Date Initiated2005-10-12
Date Terminated2008-09-22
Product Quantity784 boxes x 6 packs x 50 tests

Reason for Recall

Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.

Firm Action

Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005.

Root Cause

Other

Distribution Pattern

Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043386VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc. · 2005-02-07

Official Source

View FDA Recall →

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

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