CLASS II ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report
FlexLab (FLX) System recalled by Inpeco
Inpeco is recalling FlexLab (FLX) System, distributed in California, New York. The recall was initiated on 3 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0106-2026
- FDA event ID
- 97565
- Recalling firm
- Inpeco, Lugano
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2025
- FDA classified
- 9 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Sep 2025 | Recall initiated by company | |
| 9 Oct 2025 | Classified by FDA | +36 days |
| 15 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The FlexLab 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.
Product as listed by the FDA
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Where it was distributed
US distribution to CA & NY.
Questions about this recall
Why was it recalled?
The FlexLab 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.
Which lots are affected?
PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.
Where was it sold?
US distribution to CA & NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97565This product is part of a recall event; the main page for the event is FlexLab X (FXX) System recalled by Inpeco.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | FlexLab X (FXX) System recalled by Inpeco | Inpeco | Other | CA, NY |
More recalls from Inpeco
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab (FLX) recalled by Inpeco | Inpeco | Other | MI |
| Device | CLASS II | FlexLab X (FXX) System recalled by Inpeco | Inpeco | Other | CA, NY |
| Device | CLASS II | Roche Cobas 8000 and Cobas PRO Interface Module recalled by Inpeco | Inpeco | Other | Nationwide |
| Device | CLASS II | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation recalled | Inpeco | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |