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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Toal T4 Calibrators

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  Class 2 Device Recall VITROS Toal T4 Calibrators see related information
Date Initiated by Firm February 20, 2014
Date Posted May 21, 2014
Recall Status1 Open3, Classified
Recall Number Z-1648-2014
Recall Event ID 67643
510(K)Number K954721  
Product Classification Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
Product VITROS TT4 Calibrator

For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Code Information Catalog Number: 139 3396, Lot Number: 1590
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
FDA Determined
Cause 2
Under Investigation by firm
Action Ortho Clinical Diagnostics sent an Urgent Product Correction Notifications dated February 19, 2014, to all affected customers via Fed Ex and/or US Postal Service Priority Mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to immediately discontinue using and discard all remaining affected product. Customers should review their Quality Control results that were generated using the affected lot. Customers should consult their Laboratory Medical Director if they suspect that patient results were affected. Complete the confirmation of receipt form and return by March 4, 2014. Forward a copy of the Product Correction Notice if the product was distributed outside of your facility. Fax to : 1.888.557.3759 or 1.585.453.4110
Quantity in Commerce 583 units Total (357 units domestically & 226 units internationally)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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