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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products Total T4 Reagent Pack

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 Class 2 Device Recall VITROS Immunodiagnostic Products Total T4 Reagent Packsee related information
Date Initiated by FirmJune 02, 2016
Create DateJuly 29, 2016
Recall Status1 Terminated 3 on June 08, 2018
Recall NumberZ-2302-2016
Recall Event ID 74366
510(K)NumberK964721 
Product Classification Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
ProductVITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. 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 Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information ContactMs. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.
FDA Determined
Cause 2		Under Investigation by firm
ActionOrtho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2016-112) dated June 2, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected product to inform them that sample results generated using VITROS Total T4 Reagent Packs that are opened for more than 4 weeks may produce a negative bias and advised them to only use the Total T4 Reagent Pack up to 4 weeks after the pack has been opened. Foreign affiliates were informed of the issue by e-mail on 6June 2, 2016, and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Global Technical Solutions Center at 1-800-421-3311.
Quantity in CommerceUS: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda
DistributionWorldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KLI
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