Class 2 Device Recall Roche cobas p 612 preanalytical system

• Date Initiated by Firm: July 16, 2018
• Create Date: August 27, 2018
• Recall Status: Terminated on May 16, 2019
• Recall Number: Z-2944-2018
• Recall Event ID: 80617
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: Roche cobas p 612 pre-analytical system (63x); Model: 07563116001; ; The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.
• Code Information: All units
• Recalling Firm/ Manufacturer: Roche Diagnostics Corporation; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: SAME; 317-5214343
• Manufacturer Reason for Recall: Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Roche, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/6/18 to its customers on 7/6/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Complete all sections of the enclosed faxback form and fax it to number 1-866-469-2231 or email it to Roche6840@stericycle.com. " Ensure you have at least a two-week supply of disposable filter tips before the Roche FES arrives to modify your system. " Provide copies of this Urgent Medical Device Correction (UMDC) to other clinicians who may need to be aware of this issue. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. If you are using cobas p 612 pre-analytical (63x) (LCP1) systems for aliquoting in combination with non-filter tips, you must use filter tips until the root cause is identified and appropriate corrective actions have been implemented. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
• Quantity in Commerce: 12 units
• Distribution: US Distribution to states of: CA, NY,TX, WA, and WI.
• Total Product Life Cycle: TPLC Device Report

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.