11/19/2021 0 Comments Abbott Istat Lactate
UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.Article Snippet: Hemoglobin levels were measured using the Hemocue Hb 201+ analyzer (Brea, CA), and venous lactate values were obtained using the Abbott iStat.(25 Tests) Note: To all buyers the CG4+ is now FDA cleared Please read the iSTAT CG4 Notice product attachment prior to purchase. A whole blood sample of approximately 1 to 3I-STAT CG4+ cartridge (blue), List No. Cartridges are also available for Celite-ACT, Kaolin-ACT, PT/INR, Troponin I/cTnI, CK-MB and BNP (Table 1).NO RETURNS, REFUNDS, or EXCHANGES. REFRIGERATED-PLEASE SELECT NEXT-DAY AIR SHIPPING FOR PRODUCT STABILITY. (Old item: ABBT-07G02-01.)All cartridges from CLIAwaived.com have a 60 day shelf life or longer.
Abbott will notify customers if/when the products receive FDA clearance for use with arterial and venous whole blood samples in non-waived settings. If an alternate method is not available, the BLUE CHEM8+ and CG4+ cartridges will still be available while Abbott is working toward FDA clearance for facilities in non-waived settings (i.e., facilities that hold a Certificate of Compliance or Accreditation). The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.On , the firm notified customers of the product recall via letters, customer emails, follow-up phone calls/visits by sales representatives, and a website posting at Customers were instructed to do the following:Facilities using the i-STAT BLUE CHEM8+ cartridges in CLIA waived settings should transition to alternate CLIA waived testing methods or engage a reference laboratory for the tests your facility requires.Facilities should discontinue use of the i-STAT BLUE CHEM8+ and CG4+ cartridges with capillary samples.Facilities should use an alternate method, if available, for the tests included in the i-STAT BLUE CHEM8+ and CG4+ cartridges for arterial and venous specimens. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. Samples for pH, PCO 2, PO 2 , TCO 2 andCLIA recognizes two types of laboratory tests: waived and non-waived. Test for lactate immediately.
0 Comments
Leave a Reply. |
AuthorMike ArchivesCategories |