Instrumentation Laboratory recalled 7,720 coagulation testing devices on December 11, 2025. The recall stems from a potential for microbial contamination. Healthcare providers and patients should stop using the device immediately.
Potential for microbial contamination.
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
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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.
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.
This recall is not part of a broader industry pattern.
The recall affects the availability of coagulation testing devices for healthcare providers, which can disrupt patient monitoring and treatment plans.
The part number and UDI-DI can typically be found on the packaging or label of the device.
Expect a response regarding refund or replacement within 4-6 weeks after contacting the manufacturer.
Keep records of all communications regarding the recall, including dates and details of your requests.
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.
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