# FDA recall Z-0669-2020

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2019-10-28.

## Product

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma   Catalog number:  07026773190

## Reason for recall

Current  software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded  an erroneous Border Area setting, (1.0   1.00) instead of (0.90   1.10).

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0669-2020
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-28
- **Report date:** 2019-12-18
- **Termination date:** 2022-06-28

- **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-0669-2020

## Citation

> AI Analytics. FDA recall Z-0669-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0669-2020. Source: US FDA. Licensed CC0.

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