FDA Medical Device Recalls (openFDA)
Inpeco S.A.: FlexLab (FLX); Version: FLX-217-40;
- Recall number
- Z-0596-2026
- Recalling firm
- Inpeco S.A.
- Product
- FlexLab (FLX); Version: FLX-217-40;
- Status
- Open, Classified
- Initiated
- 2025-10-30
- Posted
- 2025-11-26
- Terminated
- not on file
- Reason
- 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
- 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: regulatory.affairs@inpeco.com.
- Quantity
- 14 units (1 US, 13 OUS)
- Distribution
- US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K121012"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 3010825766
- Firm city
- Lugano
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28