CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

FlexLab (FLX) recalled by Inpeco

Inpeco is recalling FlexLab (FLX), distributed nationwide in the US. The recall was initiated on 30 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 07640172340004 Serial number: FLX.0226;

Quantity recalled1 unit (OUS only)

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-0595-2026
FDA event ID: 97887
Recalling firm: Inpeco, Lugano, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 30 Oct 2025
FDA classified: 25 Nov 2025
Reported: 3 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Oct 2025	Recall initiated by company
25 Nov 2025	Classified by FDA	+26 days
3 Dec 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

FlexLab (FLX); Version: FLX-217-10;

Where it was distributed

US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

Nationwide Michigan

Questions about this recall

Is FlexLab (FLX) recalled?

Yes. Inpeco recalled FlexLab (FLX) on 30 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0595-2026.

Why was it recalled?

Which lots are affected?

UDI-DI: 07640172340004 Serial number: FLX.0226;

Where was it sold?

US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

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
15 Oct 2025Device	CLASS II	FlexLab (FLX) System recalled by Inpeco	Inpeco	Other	CA, NY
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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