—#116170

Product

Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.

FDA product code: OOI — Real Time Nucleic Acid Amplification System
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K110923
Affected lot / code info: Lot / SN : 477415,477416, 477898, and 477899

Why it was recalled

Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.

Root cause (FDA determination)

Process control

Action the firm took

Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made. Questions and concerns are to be addressed to Roche Molecular Diagnostics Technical Support 24 hours/day 1-800-526-1247.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.

Timeline

Recall initiated: 2013-03-01
Posted by FDA: 2013-04-01
Terminated: 2014-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116170. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.