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Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Search FDA. Food and Drug Administration. For Government For Press. Adverse Events. CFR Title Radiation-Emitting Products. X-Ray Assembler. Medsun Reports. New Search. Date Initiated by Firm February 19, Intended: For in vitro coagulation studies. Software defect in TEG Manager impacts the displayed alert for out of range test results.
Due to this defect, reference range values received from TEG and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa. This customer letter notified end users that Haemonetics is conducting a voluntary correction of all TEG Manager software used in conjunction with the TEG device.
Letter states reason for recall, health risk and action to take: Haemonetics is developing a patch to correct the issue with the TEG Manager software. The patch is expected to be available in March of Haemonetics will contact customers when the TEG Manager software patch is available for download and we will follow up with each user to ensure that the patch has been received and implemented.
Recipients of this notice should complete the attached acknowledgement form in its entirety. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
This record will be updated as the status changes.
A comparison between the TEG 6s and TEG 5000 analyzers to assess coagulation in trauma patients
Skip to main content. Published: May 14, This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures, making it the first cartridge-based system available in the U. The site-of-care TEG 6s system provides actionable test results in as little as ten minutes. The study collected more than , data points and showed that the TEG 6s system is reliable, substantially and analytically equivalent and test results can be interpreted like those from the TEG system when used in a trauma setting. The TEG 6s system, comprised of the analyzer, disposable cartridges and software, provides rapid, comprehensive and accurate identification of a patient's hemostasis condition. Featuring an innovative, all-in-one cartridge, the TEG 6s system delivers viscoelastic test results without the complicated test preparation associated with traditional blood tests.
How often is your patient at risk for thrombosis? Traditional coagulation testing is proven, but limited Routine coagulation tests are used as a starting place when investigating the cause of bleeding. They indicate the time of fibrin formation through the intrinsic and extrinsic pathways of the coagulation cascade. But what if you interrupt anti-platelet medication on a patient who is already predisposed to thrombotic events? By simply having a more thorough understanding of patients' hemostasis, unnecessary allogeneic transfusions could be avoided.
Hemostasis analyzer system Providing fast, actionable results to help you reduce risks, complications and costs. Hemostasis analyzer system For more than forty years, hospitals have been turning to Haemonetics to help reduce the risk, complications and costs associated with blood product transfusions. Since integrating Haemoscope and the TEG system into the Haemonetics family in , we have continually and increasingly invested in the clinical science and technology. Hemostasis and the need for improved assessment Hemostasis is a natural, regulated process within the coagulation continuum. A balanced system is said to be one that provides hemostasis in the right place, in the right size, at the right time. Hemostatic Balance Designed to provide a complete analysis Traditional coagulation testing is limited Routine coagulation tests are often used as a starting place when investigating This thrombin generated tracing identifies underlying hemostatic characteristics and risk of bleeding or thrombosis.