FDA recall Z-0595-2026

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

Status

Ongoing

Initiation date

2025-10-30

Report date

2025-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lugano, N/A, Switzerland

Primary source

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