Diagnostica Stago recalled 12,740 D-Dimer testing devices on September 12, 2025. The recall follows a risk of underestimating D-Dimer levels in patients. Healthcare providers and patients should stop using the device immediately.
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is the STA Liatest D-Di, REF: 00515. The affected lot numbers are 271382 and 271411, with an expiration date of September 30, 2025. The devices were distributed worldwide, including throughout the U.S. and Canada.
The recall addresses a significant risk of underestimating D-Dimer levels with the affected lots. D-Dimer tests are crucial for diagnosing blood clots, and inaccurate results may lead to serious health consequences.
No specific incidents or injuries have been reported related to this recall. However, underestimating D-Dimer levels can result in misdiagnosis of conditions like deep vein thrombosis or pulmonary embolism.
Stop using the device immediately. Follow recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for further guidance.
For more information, contact Diagnostica Stago at the number provided in the recall notification. Further details are available on the FDA's website.
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