![]() 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 ![]() All rights reserved.Class 2 Device Recall iSTAT cTnI cartridge Fingerstick testing is, however, accurate in qualifying troponin levels as negative, borderline, or positive and is, therefore, capable of providing clinical information that may guide diagnostic and therapeutic decision making.Ĭopyright © 2013 Elsevier Inc. ![]() Bland-Altman agreement analysis yielded a mean difference between fingerstick and ED POCT of -0.0095 with limits of agreement of -0.0625 to 0.0435.įingerstick cTnI testing using the i-STAT device is not accurate enough to determine the exact troponin level without the application of a corrective term. The relationship between methods appears linear, with linear regression equation ED POCT level = 0.0062 + 1.3752 * fingerstick level (P < 0.0001). Fingerstick testing, compared with standard ED POCT, has a positive predictive value of 1.00 (0.48, 1.00), negative predictive value of 0.96 (0.89, 0.99), sensitivity of 0.625 (0.24, 0.91), and specificity of 1.00 (0.95, 1.00). Four resulted in cartridge error the remaining 85 were analyzed. ![]() The data were subjected to categorical comparison, linear regression, and Bland-Altman agreement analysis using SAS 9.2 software (SAS, Cary, NC).Įighty-nine cTnI levels were measured by both fingerstick and standard venipuncture ED POC testing. Cardiac troponin I (cTnI) assays were performed using the i-STAT 1 device (Abbott Point of Care, Princeton, NJ). Fingerstick blood samples were collected from consenting patients for whom standard-of-care venipuncture POC troponin (POCT) testing had been ordered as part of their workup. This study was conducted with institutional review board approval in the emergency department (ED) of a 535-bed suburban level I trauma center from June to August 2011. The purpose of this study is to compare fingerstick point-of-care (POC) testing for cardiac troponin I to conventional venipuncture POC testing using the i-STAT device. ![]()
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