Radiometer America Inc recalls ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate,…

Recall date

January 26, 2017

Source

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

Recall number

Z-1462-2017

FDA classification

Class II

Brand / firm

Radiometer America Inc

Sold / distributed

U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.

Why it was recalled

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

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

What was recalled

ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.