Z-0595-2026 Class II Ongoing
FDA device recall Z-0595-2026 was initiated by Inpeco S.A. on October 30, 2025 and is designated Class II. 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 o… The recall status is ongoing. Affected quantity: 1 unit (OUS only).
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit (OUS only)
Product Description
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 Pattern
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
Code Information
UDI-DI: 07640172340004 Serial number: FLX.0226;