Inpeco S.A.: Medical Device Recall in 2025 - (Recall #: Z-0596-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

FlexLab (FLX); Version: FLX-217-40;

Product Classification:

Class II

Date Initiated: October 30, 2025

Date Posted: December 3, 2025

Recall Number: Z-0596-2026

Event ID: 97887

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

Status: Ongoing

Product Quantity: 14 units (1 US, 13 OUS)

Code Information:

UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046;

Distribution Pattern:

US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated