# FDA recall Z-0928-2020

> **Biomerieux Inc** · Class II · device recall initiated 2019-10-22.

## Product

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

## Reason for recall

Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration.   Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired  and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations.   The  anomaly is due to an incorrect update of the calibration status by the software.

## Distribution

US

## Key facts

- **Recall number:** Z-0928-2020
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-22
- **Report date:** 2020-02-12
- **Termination date:** 2024-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2020

## Citation

> AI Analytics. FDA recall Z-0928-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0928-2020. Source: US FDA. Licensed CC0.

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