![]() It is ideal for analytical measurement range. 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 = CHL and Original Applicant = I-STAT CORP. The Eurotrol Hyperbaric (QC High) Control is used for the validation of elevated pO2 blood gas measurements. 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. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 84 or your Abbott Point of Care representative.ġ A record in this database is created when a firm initiates a correction or removal action. Exposing the sample to air when measuring pH, PCO2 and PO2. In conclusion, PaO2 is dependent on lung functioning and SaO2 is dependent on SpO2 (dissolved O2 in the blood that eventually binds to Hgb). When testing with samples with a high concentration of potassium, decreased potassium results may be generatedĪbbott Point of Care issued recall letter on 9/13/18 via FedEx, advising of the problem, recommend action to return all unused cartridges to APOC. Incomplete filling causes higher heparin to blood ratio which will decrease ionized calcium. Therefore, a patient can have an adequate SaO2 (saturation of O2 on Hgb) but in general the lung functions can be dec. The oxygen sensor is similar to a conventional Clark electrode. The G3+ i-STAT test cartridge includes pH, PCO2, PO2, TCO2, HCO. Date: 09/29/03 PO2 is measured amperometrically. With i-STAT G3+, healthcare professionals can obtain blood gases within two minutes by the. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. PO2 AND CALCULATED OXYGEN SATURATED (sO2) Art: 714180-00C Rev. Inaccurate potassium results may be generated. Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHLĪbbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |