FDA Medical devices recall ·
FlexLab (FLX) recall
- Recall number
- Z-0595-2026
- Date
- (initiated October 30, 2025)
- Company / brand
- Inpeco S.A.
Via San Gottardo 10, Lugano, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit (OUS only)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FlexLab (FLX); Version: FLX-217-10;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 07640172340004 Serial number: FLX.0226;
Distribution
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
States: Michigan
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0595-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.