Z-0846-2021Class II

The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification...

Name: Z-0846-2021 The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification...
Creator: Roche Molecular Systems, Inc.
Published: 2020-11-19
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2020-11-19 / Terminated / root cause: design

FDA source

Roche Molecular Systems, Inc. began a recall of 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... on 2020-11-19. FDA classified it as Class II and gives the reason as "Dirty Lens May Cause Invalid or False Positive Results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0846-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Posted: 2021-01-12
Terminated: 2023-08-10
Recalling firm: Roche Molecular Systems Inc
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
Product code: MAQ Kit, Dna Detection, Human Papillomavirus
Reason for recall: Dirty Lens May Cause Invalid or False Positive Results
Root cause tag: design
FDA root 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.
Product codes and lots: All units UDI: 04015630929016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0846-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-12

Product code MAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)