#Istat lab testing code

' Facilities that continue to use the BLUE CHEM8+ and CG4+ cartridges for arterial and venous specimens should inform clinicians and laboratory staff that the performance of these cartridges has not yet been fully characterized. 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). 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:įacilities 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.įacilities should discontinue use of the i-STAT BLUE CHEM8+ and CG4+ cartridges with capillary samples.įacilities 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. 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. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status.ĬLIA recognizes two types of laboratory tests: waived and non-waived. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood. I-STAT CHEM8+ cartridges (blue), List No.

#Istat lab testing code

Electrode, ion specific, sodium - Product Code JGS