Summary
The FDA issued a Class II for FlexLab (FLX) System. Potassium Test System. in vitro diagnostic by Inpeco S.A.. Reason: The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This fu.
Details
Source
Device Recall
External ID
Z-0106-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
Product Description
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Lot/Code Info: 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.
Quantity Affected: 8 units
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.
Distribution
US distribution to CA & NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-03
Company
Lugano
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 161 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-0106-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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