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# Draeger Medical Class 1 Recall of Infant Jaundice Meter
- URL: https://www.fdaweb.com/draeger-medical-class-1-recall-of-infant-jaundice-meter/
- Published: 2018-06-08T12:00:00.000Z
- Updated: 2026-09-15T00:11:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141644

Draeger Medical Systems begun a Class 1 recall of its Draeger Jaundice Meter due to a device design flaw. Users have misinterpreted the display for out-of-range measurement indicated by a blinking “0” to mean a zero measurement, a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=164040&ref=fdaweb.com) says. The device is intended for use in hospitals and clinics to assist clinicians in monitoring newborn infants. The device is not intended as a standalone for diagnosing hyperbilirubinemia, the notice says, and should be used in conjunction with other clinical signs and laboratory measurements.