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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Recall Number Z-1735-2014
Classification Class II
Code Info Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912
Product Distributed Qty Domestic - 835 units, Foreign - 921 units
Reason For Recall Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH

Event Detail

Event Id 68271
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.