Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Inpeco S.A.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 2 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Inpeco S.A.
- Product type
- In Vitro Diagnostic System
- Model numbers
- FLX-056-40, UDI: 07640172344002, Serial No. FXX.0015.
- Sold at
- Unknown
- Where affected
- CA, NY
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The FlexLab X 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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Inpeco S.A. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The FlexLab X System is a clinical chemistry analyzer used in labs for potassium testing. It includes a Sample Integrity Module for evaluating sample quality.
Why This Is Dangerous
The HIL function was not FDA evaluated for safety/effectiveness, risking incorrect results or delays.
Industry Context
This recall is not listed as part of a broader industry pattern in the data provided.
Real-World Impact
Potential for inaccurate potassium readings or delays in patient care, necessitating immediate cessation of use.
Practical Guidance
How to identify if yours is affected
- Confirm device model FLX-056-40
- Check UDI 07640172344002 and Serial FXX.0015
- Verify distribution to CA and NY
- Note recall date 2025-09-03
Where to find product info
Refer to FDA recall page and manufacturer instructions for remediation
What timeline to expect
Refund or replacement timing not specified in data; follow manufacturer communications
If the manufacturer is unresponsive
- Document all communications
- Escalate to FDA CDRH if manufacturer unresponsive
- Seek hospital biomedical engineering support
How to prevent similar issues
- Verify FDA clearance status before enabling new diagnostic modules
- Keep devices updated per manufacturer advisories
- Maintain a log of recalls tied to lab instruments
Documentation advice
Store recall notices and email communications; record lot numbers and serials for future reference
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Product Details
Model: FLX-056-40. UDI: 07640172344002. Serial No. FXX.0015. Distribution: US to CA & NY. Quantity: 1 unit. Seller/Manufacturer: Inpeco S.A.
Reported Incidents
No incidents or injuries are reported in the provided data.
Key Facts
- California and New York distribution
- High hazard level
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Safety Guide
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