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Randox Laboratories Ltd. recalls Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This produ
Recalled April 3, 2019 · FDA recall Z-1057-2019 · Randox Laboratories
Hazard
An error in the assignment of the control range pH in Blood Gas Control · FDA Class II
Units
1 kit
Sold at
US Distribution to state of: WV
Description
An error in the assignment of the control range pH in Blood Gas Control
Product
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.
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →