Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680...
FDA Recall #Z-0755-2013 — Class II — December 13, 2012
Product Description
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.
Reason for Recall
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.
Recalling Firm
Ortho-Clinical Diagnostics — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Domestic: 15,891; Foreign: 5237
Distribution
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.
Code Information
CAT No. 680 0100; the cartridges do not have lot numbers.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated