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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent

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  Class 2 Device Recall VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent see related information
Date Initiated by Firm April 01, 2013
Date Posted June 19, 2013
Recall Status1 Terminated 3 on March 22, 2017
Recall Number Z-1556-2013
Recall Event ID 64874
510(K)Number K061588  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002.

Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Code Information Lot # 1529-17-2636, expiration date 12 June 2013
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact
800-828-6316
Manufacturer Reason
for Recall		 The firm is recalling the specific lot due to lower than expected results.
FDA Determined
Cause 2		 Process control
Action Ortho Clinical Diagnostics sent an "Important Product Correction Notification" letter dated April 1, 2013 to all affected customers. Ortho Clinical Diagnostics recommends that their customers immediately discontinue using and discard all VITROS HCY Reagent remaining in your inventory for the affected lot. They have requested that their customers complete and return the attached Confirmation of Receipt form no later than April 12, 2013. Ortho Clinical Diagnostics requested that these notifications be forwarded to all laboratories and posted beside each VITROS System that utilizes VITROS HCY Reagent within their customers facilities. To place a product order for an alternate lot, please contact Ortho Clinical Diagnostics customer service representatives at 1-800-828-6316. The VITROS Chemistry Products HCY Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure total homocysteine concentration in human serum and plasma.
Quantity in Commerce 478 total (339- Domestic) (139- International)
Distribution Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
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 = LPS and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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