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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description 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.
Recall Number Z-1648-2014
Classification Class II
Code Info Catalog Number: 139 3396, Lot Number: 1590
Product Distributed Qty 583 units Total (357 units domestically & 226 units internationally)
Reason For Recall Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

Event Detail

Event Id 67643
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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