# FDA recall Z-1107-2020

> **bioMerieux, Inc.** · Class II · device recall initiated 2019-12-10.

## Product

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

## Reason for recall

Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.

## Distribution

Distributed nationwide and 9 units to Biomerieux Canada.

## Key facts

- **Recall number:** Z-1107-2020
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-10
- **Report date:** 2020-02-19
- **Termination date:** 2021-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2020

## Citation

> AI Analytics. FDA recall Z-1107-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1107-2020. Source: US FDA. Licensed CC0.

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