Summary
The FDA issued a Class II for FlexLab (FLX); Version: FLX-217-10; by Inpeco S.A.. Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or errone.
Details
Source
Device Recall
External ID
Z-0595-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
Product Description
FlexLab (FLX); Version: FLX-217-10;
Lot/Code Info: UDI-DI: 07640172340004 Serial number: FLX.0226;
Quantity Affected: 1 unit (OUS only)
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.
Distribution
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-30
Company
Lugano, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Inpeco S.A. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inpeco S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inpeco S.A. have FDA actions?
Inpeco S.A. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0595-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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