# FDA recall Z-0846-2021

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2020-11-19.

## 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

## Reason for recall

Dirty Lens May Cause Invalid or False Positive Results

## 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, Marti

## Key facts

- **Recall number:** Z-0846-2021
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-19
- **Report date:** 2021-01-20
- **Termination date:** 2023-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2021

## Citation

> AI Analytics. FDA recall Z-0846-2021. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0846-2021. Source: US FDA. Licensed CC0.

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