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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS WorkCentre with enGen system

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  Class 3 Device Recall VITROS WorkCentre with enGen system see related information
Date Initiated by Firm March 06, 2006
Date Posted October 27, 2006
Recall Status1 Terminated 3 on June 18, 2008
Recall Number Z-0077-2007
Recall Event ID 36184
Product Classification Work Center - Product Code JQP
Product VITROS¿ WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.
Code Information Catalog # 6802159
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626
For Additional Information Contact Mr. Joseph Falvo
585-453-5735
Manufacturer Reason
for Recall		 Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
FDA Determined
Cause 2		 Other
Action On 3/06/06, all domestic end-users were sent "URGENT PRODUCT CORRECTION NOTIFICATION" letters (dated 3/06/06) by fax and FedEx, informing the users of the problem. The users were also notified by phone. OCD also notified its affiliates in France and the UK of the issue for notifying their customers of the problem.
Quantity in Commerce 3 Domestic, 6 Foreign
Distribution Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.
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.
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