Home / Recalls / Roche Molecular Systems, Inc. / Z-0846-2021

Z-0846-2021 Class II Terminated

Recalled by Roche Molecular Systems, Inc. — Branchburg, NJ

Recall Details

Product Type
Devices
Report Date
January 20, 2021
Initiation Date
November 19, 2020
Termination Date
August 10, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
597 units US; 3411 units OUS

Product 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

Reason for Recall

Dirty Lens May Cause Invalid or False Positive Results

Distribution Pattern

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.

Code Information

All units UDI: 04015630929016

Other recalls by Roche Molecular Systems, Inc.

  • Z-1104-2023 Class II — cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/880 (December 21, 2022)
  • Z-1106-2023 Class II — cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for (December 21, 2022)
  • Z-1105-2023 Class II — cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the co (December 21, 2022)
  • Z-0097-2023 Class II — cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase C (September 8, 2022)
  • Z-0828-2022 Class II — cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Nu (November 16, 2021)
  • Z-0083-2022 Class II — cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Numb (September 3, 2021)
  • Z-2498-2021 Class II — cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog (August 4, 2021)
  • Z-1414-2021 Class II — cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog (March 25, 2021)
  • Z-1413-2021 Class II — cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavi (March 25, 2021)
  • Z-0877-2021 Class II — uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 (November 23, 2020)