# FDA recall Z-0595-2026

> **Inpeco S.A.** · Class II · device recall initiated 2025-10-30.

## Product

FlexLab (FLX);  Version: FLX-217-10;

## Reason for recall

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results.  This error occurs if the operators open the printer head of  mALX to perform error recoveries or maintenance procedures and do not empty the printer  tubes buffer to remove all the secondary sample tubes.

## Distribution

US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

## Key facts

- **Recall number:** Z-0595-2026
- **Recalling firm:** Inpeco S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-30
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lugano, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0595-2026

## Citation

> AI Analytics. FDA recall Z-0595-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0595-2026. Source: US FDA. Licensed CC0.

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