Quick Facts at a Glance
- Recall Date
- December 11, 2025
- Hazard Level
- HIGH
- Brand
- Instrumentation Laboratory
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 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
- Instrumentation Laboratory
- Product type
- Coagulation Testing Device
- Model numbers
- Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 11, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for microbial contamination.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Instrumentation Laboratory or your healthcare provider for instructions. Notification method: Letter
About This Product
This coagulation testing device is used to evaluate blood coagulation pathways and monitor heparin therapy, essential for managing patients with clotting disorders. Healthcare professionals commonly use it in laboratories and hospitals to ensure patient safety and effective treatment.
Why This Is Dangerous
The risk of microbial contamination can lead to inaccurate test results and potential infections in patients. This contamination can compromise patient care, especially for those requiring precise coagulation monitoring.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects the availability of coagulation testing devices for healthcare providers, which can disrupt patient monitoring and treatment plans.
Practical Guidance
How to identify if yours is affected
- Check the part number: 0020006800
- Verify the UDI-DI: 08426950078920
- Confirm the lot number: N1136730
Where to find product info
The part number and UDI-DI can typically be found on the packaging or label of the device.
What timeline to expect
Expect a response regarding refund or replacement within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Contact a healthcare professional for advice on alternative devices.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Look for devices with recent safety certifications.
- Check for recalls before purchasing medical devices.
- Consult healthcare professionals for trusted brands.
Documentation advice
Keep records of all communications regarding the recall, including dates and details of your requests.
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Product Details
The recalled product is a coagulation testing device used for evaluating the intrinsic coagulation pathway and monitoring heparin therapy. The affected model is Part Number: 0020006800 with UDI-DI 08426950078920 and Lot Number N1136730. The expiration date is December 31, 2025.
Key Facts
- Recall Date: December 11, 2025
- Quantity Recalled: 7,720 units
- Potential for microbial contamination
- Immediate action required to stop use
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Safety Guide
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