# FDA recall Z-1195-2018

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2017-10-27.

## Product

Nucleic Acid test intended for screening for MRSA/SA.  Each kit has 20 tubes.  in vitro diagnostic.

## Reason for recall

The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection.  A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others.  The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.

## Distribution

Worldwide distribution.  Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland.  US product is not affected.

## Key facts

- **Recall number:** Z-1195-2018
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-27
- **Report date:** 2018-04-04
- **Termination date:** 2020-04-27

- **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-1195-2018

## Citation

> AI Analytics. FDA recall Z-1195-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1195-2018. Source: US FDA. Licensed CC0.

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