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Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
This recall involves Sofoliana and Glotika baby loungers. The recalled baby loungers are rectangular in shape and are made of a foam sleeping pad and padded bumpers with a cloth cover. The Sofoliana baby loungers are dark gray with a ribbon tie at the bottom of the lounger. The Glotika baby loungers zip up into a bag with an adjustable strap and came in the following colors: gray-rocket, pink-heart and white-elephant, with the printed design on the inside of the lounger. Neither baby loungers have any markings or labeling.