After finding that users are misinterpreting some of the results from its newborn jaundice meters, Draeger Medical Inc. is updating labeling, offering training and upgrading software in an action that has been designated as a highest-risk class I recall by FDA.
The recall targets two models of jaundice meters linked to misintepretations that could delay treatment.Clinicians use the Draeger Jaundice Meter JM-103 and Jaundice Meter JM-105 to measure the yellowness of...
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