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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 63934
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ortho Clinical Diagnostics VITROS® Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS® Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS® 3600, VITROS® 5600, and VITROS® ECi/ECiQ Systems. CAT No. 680 0100; the cartridges do not have lot numbers. Class II Some VITROS® Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS® System instead of the intended VITROS® Vapor Adsorption Cartridge which may bias results. Domestic: 15,891; Foreign: 5237 Z-0755-2013