Recall Z-0755-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
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.
| Date | Jan 30, 2013 (initiated Dec 13, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | Ortho-Clinical Diagnostics sent URGENT PRODUCT CORRECTION Letters (dated 12/13/12) along with Q&A and Confirmation of Receipt Forms to distributors and consignees on 12/13/12. They were advised of the issue and instructed to discard their current inventory of VITROS Vapor Adsorption Cartridges. On 12/13/12, foreign affiliates were informed by e-mail of the issue and instructed to notify their consignees of the issue and actions. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.