Lower risk Medical device recall · FDA · Published October 30, 2025

Inpeco FlexLab FLX-217-40: Label mismatch may cause test errors

Inpeco recalls FlexLab version FLX-217-40 due to label mismatch causing test errors. Affected units have specific serial numbers. Contact Inpeco for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0596-2026Medical device Inpeco ›

Lower-risk 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

Take action

Contact the company

Recalling firmInpeco S.A.Via San Gottardo 10 · Lugano, Switzerland

✎ GovInfoNow plain-language explainer

Inpeco is recalling FlexLab (FLX) version FLX-217-40 because improper maintenance can cause sample tubes to have mismatched or unlabeled labels, leading to delayed or incorrect test results. This affects lab equipment used for medical testing. Read more at govinfonow.com/recall/50863-inpeco-flexlab-flx-217-40-label-mismatch-may-cause-test.

Source Summary by GovInfoNow · govinfonow.com/recall/50863-inpeco-flexlab-flx-217-40-label-mismatch-may-cause-test · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0596-2026

Cite this page

“Inpeco FlexLab FLX-217-40: Label mismatch may cause test errors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50863-inpeco-flexlab-flx-217-40-label-mismatch-may-cause-test. Based on FDA recall #Z-0596-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2026%22&limit=1).

The FDA announced on Oct. 30, 2025, that Inpeco S.A. is recalling its FlexLab (FLX) device, version FLX-217-40, due to a hazard involving unlabeled or mismatched secondary sample tubes. This issue may result in delayed or erroneous test results.

How to tell if you have it

Brand: Inpeco
Product: FlexLab (FLX)
Version: FLX-217-40
UDI-DI: 07640172344002
Serial numbers: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046
Quantity: 14 units

The hazard

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels if operators open the printer head for maintenance and do not empty the buffer. This error may result in delayed results or erroneous results.

Context

GovInfoNow's records show Inpeco S.A. has 13 other recalls on record since 2018-02-13. Other recent recalls of similar products include Inpeco FlexLab X Potassium Test System Recall (2025-09-03), Roche Cobas 8000 Interface Module Recall (2023-11-03), and Inpeco Alinity h Interface Module Recall (2023-03-10). Other recent recalls of similar products include Omnicell i.v.Station Label Stock Recall (2026-03-25), CONSTRUX Mini PTC Spacer System: Labeling Inconsistencies Recalled (2025-11-03), and Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07).

How to tell if you have this one

Check for serial numbers: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046. The affected units are version FLX-217-40 of the FlexLab device.

Brand
Inpeco
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

Recall number	Product, codes & lots	Quantity
Z-0595-2026	FlexLab (FLX); Version: FLX-217-10;; UDI-DI: 07640172340004 Serial number: FLX.0226;	1 unit (OUS only)
Z-0596-2026	FlexLab (FLX); Version: FLX-217-40;; UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046;	14 units (1 US, 13 OUS)

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify your FlexLab unit's serial number against the list: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046.

Where it went and when

Where it was distributed

Distributed in Michigan, and outside the U.S.

FDA distribution: “US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan.

Recall timeline

FDA published this recall 34 days after the firm started it.

Oct 30, 2025Firm started the recall
Nov 25, 2025FDA classified it Class II
Dec 3, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50863-inpeco-flexlab-flx-217-40-label-mismatch-may-cause-test">Inpeco FlexLab FLX-217-40: Label mismatch may cause test errors (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0596-2026 (October 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0596-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.