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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS VANC (vancoymycin) Reagent

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  Class 2 Device Recall VITROS VANC (vancoymycin) Reagent see related information
Date Initiated by Firm October 12, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on September 22, 2008
Recall Number Z-0173-06
Recall Event ID 33896
510(K)Number K043386  
Product Classification Radioimmunoassay, Vancomycin - Product Code LEH
Product VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
Code Information 01-5919, Exp. 5/31/2005 (EXPIRED):  01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Judy M. Strzepek
Manufacturer 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.
FDA Determined
Cause 2
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.
Quantity in Commerce 784 boxes x 6 packs x 50 tests
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LEH and Original Applicant = Ortho-Clinical Diagnostics, Inc.