FDA Medical Device Recalls (openFDA)
Inpeco S.A.: FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
- Recall number
- Z-0107-2026
- Recalling firm
- Inpeco S.A.
- Product
- FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
- Status
- Open, Classified
- Initiated
- 2025-09-03
- Posted
- 2025-10-09
- Terminated
- not on file
- Reason
- The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
- Root cause
- No Marketing Application
- Action
- Consignees received an Urgent Medical Device Recall notification via email dated 9/3/25. The notification instructs consignees to not rely on HIL functionality for clinical decision making or to flag potentially erroneous samples. HIL functionality must be discontinued and cannot be disabled by users. Inspeco must send an Inspeco Servicer to consignee locations to disable HIL functionality. Inspeco will contact consingnees to schedule this service. Consignees are to forward the provided notification to those whom it might concern. Consignees with questions can contact Regulatory Affairs via email at regulatory.affairs@inspeco.com or Inspeco Service Team via email at service.NA@inspeco.com.
- Quantity
- 1 unit
- Distribution
- US distribution to CA & NY.
- Lot, serial or model codes
- PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
- 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