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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Molecular Systems cobas 4800 System

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 Class 2 Recall
Roche Molecular Systems cobas 4800 System
see related information
Date Posted April 01, 2013
Recall Status1 Open
Recall Number Z-1028-2013
Recall Event ID 64453
Premarket Notification
510(K) Number
K110923 
Product Classification Real Time Nucleic Acid Amplification System - Product Code OOI
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.
Code Information Lot / SN : 477415,477416, 477898, and 477899
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis, Indiana 46256-1025
For Additional Information Contact Todd Siesky
317-576-2000 Ext. 249
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action 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.
Quantity in Commerce 189 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = ROCHE MOLECULAR SYSTEMS, INC.
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