The i-STAT was subsequently chosen for measurement of ACT in the OR. However, we found that the iSTAT ACT-K cartridge performed with better precision and cross-device reproducibility than the Hemochron Signature Elite (Kaolin ACT+ cartridges) for patient samples.

Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. There was reasonable correlation between ACT results from each. 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. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 80, Option 1 or your Abbott Point of Care representative.ġ A record in this database is created when a firm initiates a correction or removal action. All unused cartridges will be credited and will be returned. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material.

If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. The letter identified the product, the problem, and the action to be taken by the customer.Ĭustomers were instructed to discontinue use of cartridges from the identified lots. sent an URGENT RECALL NOTICE dated September 2010 on Octoby Federal Express to all US customers. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Other applications and ACT target ranges using ACT with Celite activation are listed in the following table.Class 2 Device Recall iSTAT ACT Kaolin CartridgesĪctivated whole blood clotting time - Product Code JBP At the completion of CPB, heparin is neutralized with protamine and the ACT is performed again to ensure that it has returned to baseline levels. During bypass, the ACT is repeated every 15 to 20 minutes if the result is less than 450 seconds, additional heparin is administered. The baseline ACT should be shorter than 200 seconds and the postheparinization ACT should be longer than 450 seconds prior to the onset of bypass. Heparinized patients, however, showed a bias with iSTAT ACT results, on average, 60 seconds longer than Hemochron Jr. The reference range (baseline) of 70-140 seconds was comparable. The usual monitoring protocol consists of a baseline ACT followed by a bolus of heparin. device previously used in the Stanford Operating Room. As a result, it is linearly responsive to the high concentrations of heparin used during bypass (1-5 U/mL). The ACT is a test of whole blood that uses a strong contact activator of the intrinsic coagulation pathway, either celite or kaolin. For example, heparin concentrations between 1 and 3 units/mL give ACT results ranging between 130 and 350 seconds. The ACT is designed to be prolonged about 100 seconds above baseline for each unit per milliliter of heparin concentration in a typical patient. The APTT is unsuitable at this level of heparinization, as it is frequently prolonged beyond the measurable range. The ACT correlates with the anticoagulant effect of heparin at the higher heparin levels used in these procedures. On the other hand, the ACT is the recommended test for monitoring heparin in interventional cardiology procedures. The APTT is preferred to the ACT for monitoring standard heparin therapy (for treatment of venous thromboembolism, unstable angina, myocardial infarction etc.), because it shows significantly better precision and is less subject to technical variability. If unexpected test results are obtained, more specific coagulation tests should be performed for further investigation. ACT is prolonged in patients with antiphospholipid antibodies and may not demonstrate a linear response to heparin. Other factors that may affect the ACT include hemodilution, hypothermia, cardioplegic solutions, platelet dysfunction, hypofibrinogenemia, other coagulopathies and certain drugs.

The degree of prolongation of the ACT is a useful index of a patient's level of anticoagulation, and the heparin dose may be adjusted according to the result.

Changes in the ACT are directly and linearly proportional to the concentration of heparin. The activated whole blood clotting time is a rapid bedside test for monitoring heparin anticoagulation.

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