FDA-Device2019-04-03Class II
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Randox Laboratories Ltd.
Hazard
An error in the assignment of the control range pH in Blood Gas Control
Sold states
US Distribution to state of: WV
Affected count
1 kit
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1057-2019Don't want to check this manually?
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