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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products

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  Class 3 Device Recall VITROS Chemistry Products see related information
Date Initiated by Firm May 09, 2013
Date Posted June 27, 2013
Recall Status1 Terminated 3 on June 12, 2015
Recall Number Z-1615-2013
Recall Event ID 65247
Product Classification C-reactive protein, antigen, antiserum, and control - Product Code DCK
Product VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990,

Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013). The term GEN and Coating refer to specific segments of the reagent lot number.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
FDA Determined
Cause 2		 Employee error
Action Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 9, 2013 via FedEx or US Priority Mail to all US customers. Foreign Affiliates were notified by e-mail on May 9, 2013 informing them of the issue. Distributors were instructed to notify their customers of the recall. Customers were instructed to discontinue use, discard the affected product, comp[lete and return the attached Confirmation of Recipt Form, and post this notification by each VITROS System. For questions call Customer Service Center at 1-800-828-6316.
Quantity in Commerce Domestic: 4,257; Foreign: 923
Distribution Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain 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.
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