medical Class II Updated 2019-04-03

Randox Laboratories Ltd. recalls Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Di

Recalled 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.


Hazard / Issue

An error in the assignment of the control range pH in Blood Gas Control

Issued by

FDA

Affected States: WV
Lot/Code Info: Lot Code: 184BG GTIN: 05055273227116
View official government recall

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