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
Enforcement
- Recall Number
- Z-0846-2021
- Event ID
- 86879
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Molecular Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 20, 2021
- Initiation Date
- November 19, 2020
- Classification Date
- January 12, 2021
- Termination Date
- August 10, 2023
- Address
- 1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States
Description
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
Dirty Lens May Cause Invalid or False Positive Results
All units UDI: 04015630929016
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.
597 units US; 3411 units OUS