| Class 2 Device Recall VITROS Chemistry Products Vapor Adsorption Cartridge | |
Date Initiated by Firm | December 13, 2012 |
Date Posted | January 30, 2013 |
Recall Status1 |
Terminated 3 on July 05, 2018 |
Recall Number | Z-0755-2013 |
Recall Event ID |
63934 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | 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. |
Code Information |
CAT No. 680 0100; the cartridges do not have lot numbers. |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact | Ms. Jennifer Paine 908-218-8776 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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