Class 2 Device Recall VITROS CHEMISTRY PRODUCTS TRIG Slides

• Date Initiated by Firm: November 06, 2014
• Date Posted: December 22, 2014
• Recall Status: Terminated on February 28, 2017
• Recall Number: Z-0848-2015
• Recall Event ID: 69791
• 510(K)Number: K812029
• Product Classification: Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
• Product: VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) 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: Lot 0704-3318-4774 (expiry date 01 Dec 2015)
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 513 Technology Blvd; Rochester NY 14626-3601
• For Additional Information Contact: Ms. Jennifer Paine; 908-218-8776
• Manufacturer Reason for Recall: Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Ortho Clinical Diagnostics sent an Urgent Product Correction Notification dated November 6, 2014, via FedEx overnight courierand/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all affected customers. The letter identified the product, the problem, and the acton to be taken by the customer. The letter informed the customers of the issue and advise them to discontinue use of the affected lot and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. For additional questions, please contact OCD's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
• Quantity in Commerce: USA: 380 units, Foreign: 155 units
• Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, 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.

• 510(K) Database: 510(K)s with Product Code = CDT