# FDA recall Z-1413-2021

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2021-03-25.

## Product

cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System,   Catalog Number: 09211101190

## Reason for recall

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

## Distribution

Nationwide  WorldWide

## Key facts

- **Recall number:** Z-1413-2021
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-25
- **Report date:** 2021-04-21

- **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-1413-2021

## Citation

> AI Analytics. FDA recall Z-1413-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1413-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*