Class 2 Device Recall cobas 4800 System, cobas z 480 analyzer

• Date Initiated by Firm: November 19, 2020
• Create Date: January 12, 2021
• Recall Status: Terminated on August 10, 2023
• Recall Number: Z-0846-2021
• Recall Event ID: 86879
• PMA Number: P100020
• Product Classification: Kit, dna detection, human papillomavirus - Product Code MAQ
• Product: The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system.; ; The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer.; ; In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays:; cobas¿ 4800 BRAF V600 Mutation Test; cobas¿ Cdiff Test for use on the cobas¿ 4800 System ; cobas¿ CT/NG v2.0 Test ; cobas¿ EGFR Mutation Test v2 ; cobas¿ Factor II and Factor V Test; cobas¿ 4800 HPV Test; cobas¿ HSV 1 and 2 Test for use on the cobas¿ 4800 System; cobas¿ KRAS Mutation Test ; cobas¿ MRSA/SA Test for use on the cobas¿ 4800 System
• Code Information: All units UDI: 04015630929016
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 US Highway 202 S; Branchburg NJ 08876-3733
• For Additional Information Contact: SAME; 908-253-7200
• Manufacturer Reason for Recall: Dirty Lens May Cause Invalid or False Positive Results
• FDA Determined Cause: Device Design
• Action: Roche issued Urgent Medical Device Correction on 11/19/20 via UPS Ground (receipt required). Letter states reason for recall, health risk and action to take: Inform any operators that use the cobas z 480 analyzer of the potential hazards associated with this issue and provide a copy of this notification, as appropriate. " Ensure the AD-plates are sealed properly before performing amplification/detection on your cobas z 480 analyzer(s). " Refer to the cobas 4800 System User Assistance/cobas 4800 System Operators Manual in the section To seal the microwell plate for detailed instructions on how to properly seal the amplification/detection plate prior to loading on the cobas z 480 analyzer. Note: Review the additional warning messages in the General Safety sections that highlight recommendations for avoiding incorrect handling, risk of incorrect results, or contamination of the analyzer due to lack of proper sealing of the microwell plate. " Follow laboratory standard operating procedures to investigate the potential for false positive results for assays where a change in result reporting could impact patient management. " Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients Contact the Roche Support Network Customer Support Center at 1-800-526-1247 if you determine that you are observing false positive results, experiencing a higher than usual number of invalid results, or observing that an unsealed/improperly sealed plate was used during a run. " Complete the attached faxback form (TP-01092) and fax or email it according to the instructions on the form. " If your facility has distributed cobas z 480 analyzers to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. A Roche Field Service Engineer (FSE) will perform an inspection of the Optical Lens Detection Unit on your cobas z 480 analyzer(s). If the optical lens is found to be dir
• Quantity in Commerce: 597 units US; 3411 units OUS
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands, Switzerland, Czech Republic, Romania, Sweden, Norway, Denmark, Hungary, Ireland, Slovakia, Croatia, Bulgaria, Finland, Lithuania, Bosnia-Herz, Slovenia, Iceland, Estonia, Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Mongolia, Myanmar, New Zealand, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam, Argentina, Aruba, Bahamas, Barbados, Belize, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Rep., Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Panama, Paraguay, Peru, Uruguay, Venezuela, Iran, Israel, Kazakhstan, Kosovo, Lebanon, Macedonia, Oman, Russia, Saudi Arabia, South Africa, Sudan, Ukraine, UAE, Serbia, Montenegro, Algeria, Azerbaijan, Botswana, Burkina-Faso, Ethiopia, French Guayana, Gabon, Ghana, Guadeloupe, Lesotho, Martinique, Morocco, Nicaragua, Senegal, Sri Lanka, Tanzania, Tunisia, Uzbekistan, Zambia.
• 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.

• PMA Database: PMAs with Product Code = MAQ and Original Applicant = Roche Molecular Systems, Inc.