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U.S. Department of Health and Human Services

Class 2 Device Recall Vitros

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  Class 2 Device Recall Vitros see related information
Date Initiated by Firm September 29, 2005
Date Posted November 15, 2005
Recall Status1 Terminated 3 on July 31, 2007
Recall Number Z-0137-06
Recall Event ID 33848
510(K)Number K962919  
Product Classification Fluorometer, For Clinical Use - Product Code KHO
Product Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
Code Information All Vitros ECi units currently on the market (software version 3.1 or lower).
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626
For Additional Information Contact Judy M. Strzepek
908-218-8524
Manufacturer Reason
for Recall		 When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negtively biased.
FDA Determined
Cause 2		 Other
Action Letters dated 9/29/2005 issued to all domestic customers of the VITROS ECi/ECiQ systems and to Ortho/J&J foreign affiliates. Customers instructed to immediately discontinue using reflex processing to the VITROS Anti-HBc IgM and VITROS Anti-HAV reagent packs.
Quantity in Commerce 3,507 Vitros ECi units distributed
Distribution Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
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 = KHO and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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