Randox Laboratories Ltd. recalls Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product…

Recall date

February 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1057-2019

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Distribution to state of: WV

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.