FDA Device recall Z-0107-2026
FlexLab X (FXX) System
- FDA Device
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of FlexLab X (FXX) System by Inpeco, citing 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 evaluat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0107-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-03 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Inpeco |
| Distribution | CA, NY |
Product
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
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.
Identifiers
| code_info | PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Inpeco
- FlexLab (FLX)
FDA Device · Class II · 2025-12-03 · Inpeco - FlexLab (FLX)
FDA Device · Class II · 2025-12-03 · Inpeco - FlexLab (FLX) System
FDA Device · Class II · 2025-10-15 · Inpeco - Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytic…
FDA Device · Class II · 2023-12-27 · Inpeco - Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Apti…
FDA Device · Class II · 2023-05-10 · Inpeco
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0107-2026%22
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