FlexLab FLX-217-10 (Inpeco) – Labeling Mismatch Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FlexLab (FLX); Version: FLX-217-10;
Brand
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
Lot Codes / Batch Numbers
UDI-DI: 07640172340004 Serial number: FLX.0226
Products Sold
UDI-DI: 07640172340004 Serial number: FLX.0226;
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland is recalling FlexLab (FLX); Version: FLX-217-10; due to The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or errone. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On October 30, 2025, "Urgent: Medical Device Correction" letters were sent to customers. Action to be taken: To avoid the occurrence of the described issue Inpeco recommends removing all the secondary sample tubes in the printer tubes buffer (red arrow) each time the printer cover (blue arrow) is opened for error recoveries and for preventive maintenance procedures. Your service provider will contact you to schedule the service visit to implement the corrective actions which include the installation of a new sensor, the software and firmware upgrade, and the operations manual update. Transmission of this Customer Letter: Until the service visit, please maintain awareness on this notice and apply the action recommended above. Please transfer this notice to whom it might concern. Please complete and return the Customer Letter Receipt Confirmation and Implementation Check form attached to this letter within 30 days directly to the email address specified in the email communication. If you have any questions, contact the Regulatory Affairs Department via email: regulatory.affairs@inpeco.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI
Page updated: Jan 10, 2026