Roche Molecular Systems, Inc.: 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

Recall number

Z-0846-2021

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

Status

Terminated

Initiated

2020-11-19

Posted

not on file

Terminated

2023-08-10

Reason

Dirty Lens May Cause Invalid or False Positive Results

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

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.

Lot, serial or model codes

All units UDI: 04015630929016

510(k) numbers

not on file

PMA numbers

["P100020"]

Product code

MAQ

Firm FEI

2243471

Firm city

S Branchburg

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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