IR Links for Portable Clinical Analyzers, Downloaders and Downloader/Rechargers for the i-STAT1 Analyzers and a Philips installed server for Blood Analysis Modules allow for transmission of patient records from a widely distributed network of analyzers to the Central Data Station program. The i-STAT1 Analyzer is capable of using the Abbott MediSense Precision PCx or PCx Plus Blood Glucose Test Strips.Ī dedicated desktop computer with the i-STAT Central Data Station program provides the primary information management capabilities for the i-STAT System. A whole blood sample of approximately 1 to 3 drops is dispensed into the cartridge sample well, and the sample well is sealed before inserting it into the analyzer. Cartridges are also available for Celite-ACT, Kaolin-ACT, PT/INR, and Troponin I/cTnI (Table 1). Sensors for analysis of pH, PCO 2, PO 2, sodium, potassium, chloride, ionized calcium, glucose, lactate, creatinine, urea nitrogen (BUN) and hematocrit are available in a variety of panel configurations. MediSense Precision PCx or PCx Plus Glucose Test Strip: 20 secondsĪ single-use disposable cartridge contains microfabricated sensors, a calibrant solution, fluidics system, and a waste chamber. Other cartridges: typically 130 to 200 seconds PT/INR cartridge: to detection of end point – up to 300 seconds (5 min.) A MediSense ® Precision PCx ™ or PCx ™ Plus Glucose Test Strip is scanned and inserted into the i-STAT1 Analyzer and a drop of whole blood is applied to the target area of the test strip.ĪCT cartridge: to detection of end point - up to 1000 seconds (16.7 min.) When a sample-filled i-STAT cartridge is inserted into an analyzer for analysis, the analyzer automatically controls all functions of the testing cycle including fluid movement within the cartridge, calibration and continuous quality monitoring. The System consists of the following primary components:Īnalyzers can be the i-STAT Portable Clinical Analyzer, the i-STAT1 Analyzer, or the Blood Analysis Module, which is used in conjunction with the Philips Medical Systems (formerly Agilent Technologies) CMS and 24/26 Patient Monitor. The i-STAT® System incorporates comprehensive components needed to perform blood analysis at the point of care. Quality Control.Ĭalibration.Ĭlinical Significance. Supplies and Storage Requirements.īlood Specimens. 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.ĥ10(K)s with Product Code = JPI and Original Applicant = I-STAT CORP.System Overview. 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. Worldwide distribution: USA and Argentina Austria Bahamas Bolivia Brazil Chile Hong Kong China China Columbia Costa Rica Denmark Dominican Republic Ecuador El Salvador Finland Georgia Greece Honduras India India Ireland Israel Italy Japan Kuwait Mauritius Mexico Norway Oman Panama Paraguay Peru Poland Portugal Qatar Russian Federation Saudi Arabia Singapore South Africa South Korea Spain Switzerland Taiwan Thailand Trinidad and Tobago Turkey United Arab Emirates Uruguay Yemen Netherlands Antilles Venezuela Australia Belgium France Germany Italy New Zealand Spain Sweden and The Netherlands.ġ A record in this database is created when a firm initiates a correction or removal action. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 80 or your Abbott Point of Care representative. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing, and to provide a copy of the letter another facility, if they have forwarded any cartridges. The letter describes the product, problem and the action to be taken by the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.Ībbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle. The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Class 2 Device Recall iSTAT E3 cartridgesĭevice, Hemocrit measuring - Product Code JPI
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |