# FDA recall Z-2362-2019

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2019-07-16.

## Product

Roche Elecsys Anti-CCP Immunoassay  Catalog # 05031656160

## Reason for recall

Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

## Distribution

AZ  CA  FL  HI  IA  IL  IN  KY  LA  MA  MI  MO  MT  NJ  NY  OK  OR  PA  PR  SC  TX  VA

## Key facts

- **Recall number:** Z-2362-2019
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-16
- **Report date:** 2019-09-04
- **Termination date:** 2021-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2019

## Citation

> AI Analytics. FDA recall Z-2362-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2362-2019. Source: US FDA. Licensed CC0.

---

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