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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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.
The device poses a high risk due to potential microbial contamination. This contamination can lead to serious health complications for patients relying on accurate coagulation assessments.
Currently, there are no reported incidents or injuries associated with the contamination hazard. However, the potential for serious health risks necessitates immediate action.
Stop using the coagulation testing device immediately. Follow the manufacturer's recall instructions and contact Instrumentation Laboratory or your healthcare provider for further guidance.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1095-2026.
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