Istat hemoglobin 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.ĥ10(K)s with Product Code = JPI and Original Applicant = I-STAT CORP. The test for hematocrit, as part of the i-STAT System, is intended for use in the in vitro quantification of packed red blood cell volume fraction in arterial. 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. Hematocrit, pH, PCO2, PO2, TCO2, HCO3, BEecf, sO2, Hemoglobin iSTAT System Critical Blood Analyzer.
Istat hemoglobin manual#
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. The concentration of glycated haemoglobin (HbA1c) is a surrogate measure for the average circulating glucose level over the previous 120. The main function of hemoglobin is to carry oxygen from the lungs to the body tissues, and to exchange the oxygen for carbon dioxide, and then carry the carbon dioxide back to the lungs and where it is exchanged for oxygen. Class 2 Device Recall iSTAT EG7 cartridgesĭevice, Hemocrit measuring - Product Code JPI Hemoglobin (sometimes abbreviated as Hb) is a complex protein found in red blood cells that contains an iron molecule.
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