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 | Letter |
| 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 |
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