# FDA recall Z-1059-2022

> **bioMerieux, Inc.** · Class II · device recall initiated 2022-03-29.

## Product

VITEK 2 Systems and VITEK 2 with MYLA.

## Reason for recall

Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation.  This can potentially lead to incorrect final screen/synergy test results at the LIS.

## Distribution

U.S. distribution of the FSCA to NC.  OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-1059-2022
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-29
- **Report date:** 2022-05-18

- **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-1059-2022

## Citation

> AI Analytics. FDA recall Z-1059-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1059-2022. Source: US FDA. Licensed CC0.

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