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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/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Judy M. Strzepek
908-218-8524
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		 Other
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.
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