Z-0595-2026Class II

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

Name: Z-0595-2026 FlexLab (FLX); Version: FLX-217-10
Creator: Inpeco S.A.
Published: 2025-10-30
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2025-10-30 / Open, Classified / root cause: design

FDA source

Inpeco S.A. began a recall of FlexLab (FLX); Version: FLX-217-10 on 2025-10-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0595-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-30
Posted: 2025-11-26
Recalling firm: Inpeco S.p.A.
Product: FlexLab (FLX); Version: FLX-217-10;
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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: [email protected].
Quantity in commerce: 1 unit (OUS only)
Distribution: US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
Product codes and lots: UDI-DI: 07640172340004 Serial number: FLX.0226;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0595-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0595-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-25
Z-0596-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-25

Product code CEM

K121012Class IIFlexlab 3.6, Accelerator A3600Inpeco S.P.A. / cleared 2012-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)