—#115070

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: CAT No. 680 0100; the cartridges do not have lot numbers.

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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.

Timeline

Recall initiated: 2012-12-13
Posted by FDA: 2013-01-30
Terminated: 2018-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115070. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.