# FDA recall Z-1515-2022

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2022-07-14.

## Product

cobas e801 Immunoassay Analyzer

## Reason for recall

Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

## Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, DC & PR.

## Key facts

- **Recall number:** Z-1515-2022
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-14
- **Report date:** 2022-08-17

- **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-1515-2022

## Citation

> AI Analytics. FDA recall Z-1515-2022. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1515-2022. Source: US FDA. Licensed CC0.

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