# FDA recall Z-0097-2023

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2022-09-08.

## Product

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

## Reason for recall

Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.

## Distribution

International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.

## Key facts

- **Recall number:** Z-0097-2023
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-09-08
- **Report date:** 2022-10-26
- **Termination date:** 2024-11-07

- **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-0097-2023

## Citation

> AI Analytics. FDA recall Z-0097-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0097-2023. Source: US FDA. Licensed CC0.

---

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