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

Lot, batch or date codesPN: 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.

Quantity recalled8 units

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: E-Mail
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.

California New York

Questions about this recall

Is FlexLab (FLX) System recalled?

Yes. Inpeco recalled FlexLab (FLX) System on 3 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0106-2026.

Why was it recalled?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Inpeco

All 33

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	FlexLab (FLX) recalled by Inpeco	Inpeco	Other	Nationwide
3 Dec 2025Device	CLASS II	FlexLab (FLX) recalled by Inpeco	Inpeco	Other	Nationwide
15 Oct 2025Device	CLASS II	FlexLab X (FXX) System recalled by Inpeco	Inpeco	Other	CA, NY
27 Dec 2023Device	CLASS II	Roche Cobas 8000 and Cobas PRO Interface Module recalled by Inpeco	Inpeco	Lead & Heavy Metals	Nationwide
10 May 2023Device	CLASS II	FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation recalled	Inpeco	Lead & Heavy Metals	Nationwide

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