Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Inpeco
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 2 states
- At-Risk Groups
- GENERAL
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
- Product type
- Potassium Test System
- Model numbers
- FLX-056-01, FLX-056-11, FLX-0204, FLX-0205, FLX-0209, FLX-0210, FLX-0216, FLX-0220 +2 more
- 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 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 System is a laboratory instrument used for clinical chemistry testing. The Potassium Test System is part of this platform. The Sample Integrity Module verifies sample quality indicators such as HIL. This recall concerns the HIL function within SIM.
Why This Is Dangerous
The SIM HIL function has not been evaluated by the FDA for safety and effectiveness. Using it may lead to incorrect results or delays in reporting patient results.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Healthcare labs may experience data integrity issues or result delays if HIL data is unreliable, potentially affecting patient care and workflow.
Practical Guidance
How to identify if yours is affected
- Check model numbers and serials: FLX-056-01, FLX-056-11, FLX-0204, FLX-0205, FLX-0209, FLX-0210, FLX-0216, FLX-0220, FLX-0221, FLX-0222.
- Look for UDI 07640172340004 with Serial FLX.0204.
- Review facility inventory for FlexLab FLX System units.
Where to find product info
Identifiers are on device labels, packaging, and the associated documentation provided with the unit.
What timeline to expect
There is no public timeline provided in the recall for refunds or replacements. Expect manufacturer guidance via recall notice updates.
If the manufacturer is unresponsive
- Document attempts to contact Inpeco S.A. and facility leadership.
- If the manufacturer is unresponsive, contact the FDA for guidance on next steps.
How to prevent similar issues
- Verify FDA clearance and safety validation for all HIL-related features before deployment.
- Maintain an up-to-date inventory of critical diagnostic modules and their recall status.
- Establish a protocol to quarantine devices under recall and document communications.
Documentation advice
Keep a copy of the recall notice, inventory lists, serial numbers, dates of purchase, internal communications, and any correspondence with the manufacturer.
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Product Details
Model numbers: FLX-056-01, FLX-056-11, FLX-0204, FLX-0205, FLX-0209, FLX-0210, FLX-0216, FLX-0220, FLX-0221, FLX-0222. Sold in the United States with distribution to California and New York. Quantity: 8 units. Brand: Inpeco. Status: Active recall. SoldFrom: Unknown. SoldTo: CA, NY. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US distribution to CA & NY
- HIL function not FDA evaluated
- Possible erroneous results or delayed results
- Stop using immediately
- Model numbers include FLX-056-01, FLX-056-11, FLX-0204, FLX-0205, FLX-0209, FLX-0210, FLX-0216, FLX-
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