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

Recalled March 22, 2017 · FDA recall Z-1462-2017 · Radiometer America

Hazard

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

Units

9,688

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Radiometer America Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →