For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.Ībbott - A Leader in Rapid Point-of-Care Diagnostics. Check with your local representative for availability in specific markets. Not all products are available in all regions. GDPR Statement (last updated: May 2018) | California Transparency in Supply Chains Act | Declaration for California Compliance Law. Any person depicted in such photographs is a model. Photos displayed are for illustrative purposes only. Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy: US Citizens | Non-US Citizens.
#ABBOTT ISTAT REGISTRATION#
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#ABBOTT ISTAT CODE#
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.©2022 Abbott. 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.
#ABBOTT ISTAT ARCHIVE#
A line drawing of the Internet Archive headquarters building façade. 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. Due to a planned power outage on Friday, 1/14, between 8am-1pm PST, some services may be impacted. 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. Intended Use: The i-STAT 1 Analyzer is intended for use with i-STAT cartridges. 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. i-STAT is a trademark of the Abbott group of companies. 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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