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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS CHEMISTRY PRODUCTS TRIG Slides

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  Class 2 Device Recall VITROS CHEMISTRY PRODUCTS TRIG Slides see related information
Date Initiated by Firm November 06, 2014
Date Posted December 22, 2014
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = EASTMAN KODAK COMPANY
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