9/11/2023 0 Comments Istat troponin procedure![]() ![]() Regression analysis for the i-STAT cTnI between whole blood and plasma specimens and for whole blood between the i-STAT and Stratus CS cTnI assays demonstrated slopes of 1.06 and 0.89, respectively. ![]() ![]() An equimolar response within 5% was found for reduced and phosphorylated forms of TIC and IC complexes. The assay was not affected by common interferents. The 99th percentile reference limit was 0.08 microg/l. Total imprecision (CV) of 10% and 20% were seen at 0.09 and 0.07 microg/l, respectively. Factors studied included antibody specificity, detection limit, imprecision, linearity, assay specificity, sample type stability, interferences, reference limit determination and comparison vs. A total of 186 whole blood specimens (lithium heparin) were collected from patients presenting with symptoms suggestive of acute coronary syndromes (ACS) for correlation studies as well as from 162 healthy subjects for reference interval determination. Three different hospitals participated in a patient specimen and analytical validation study (n=186) for the i-STAT cTnI assay carried out in real time. 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.This study determines the analytical characteristics of the i-STAT cardiac troponin I assay (cTnI i-STAT, Princeton, NJ), a 10-min POC assay, designed to be performed at the bedside. 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. US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WYġ A record in this database is created when a firm initiates a correction or removal action. We appreciate your understanding in this matter and thank you for your continued support of Abbott and Abbott products. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-86, or via email at or contact your Abbott Point of Care support services representative. If you have forwarded any i-STAT cTnI blue cartridges to another facility, please provide a copy of this letter to them. If your facility repeatedly observes the i-STAT cTnI blue cartridges from a single lot generating a higher than expected number of QCCs, please contact APOC Technical Services for support and to report the information. Your Abbott Point of Care representative will contact you to discuss the details and timing of this transition for your facility. It further explains to customers while the i-STAT cTnI blue cartridges can continue to be used for patient testing, APOC recommends that all users of the i-STAT System be informed of the possibility of a higher than expected number of quality check codes while using the i-STAT cTnI blue cartridge and maintain a validated alternate backup method until the i-STAT cTnI white cartridges are received. The i-STAT cTnI blue cartridge, list number 06P23-25, will be discontinued for sale in the United States as of January 1, 2020. customers using the i-STAT cTnI blue cartridge, list number 06P23-25, to the i-STAT cTnI white cartridge, list number 03P90-25, beginning in November 2019. It explains Abbott Point of Care has made the decision to transition U.S. On Octothe firm distributed Urgent Medical Device Recall Communication letters by mail. The observed rate of quality check codes could be in the 3 to 5% range. I-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. Immunoassay method, troponin subunit - Product Code MMI Class 2 Device Recall iSTAT cTnI cartridge ![]()
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