# FDA recall Z-2498-2021

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2021-08-04.

## Product

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

## Reason for recall

Customers have reported an increased number of false positive SARS-CoV-2 results.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.

## Key facts

- **Recall number:** Z-2498-2021
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-04
- **Report date:** 2021-09-29
- **Termination date:** 2024-02-23

- **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-2498-2021

## Citation

> AI Analytics. FDA recall Z-2498-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2498-2021. Source: US FDA. Licensed CC0.

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