# FDA recall Z-0815-2024

> **Diasorin Inc.** · Class II · device recall initiated 2023-12-13.

## Product

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

## Reason for recall

DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C  136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-0815-2024
- **Recalling firm:** Diasorin Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-13
- **Report date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stillwater, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0815-2024

## Citation

> AI Analytics. FDA recall Z-0815-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0815-2024. Source: US FDA. Licensed CC0.

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