Dräger Jaundice Meter JM-103 and JM-105 (2018-05-09)

Starting date:

May 9, 2018

Posting date:

May 18, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66804

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  Reason
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  Affected products

Affected products

A. DRAGER JAUNDICE METER JM-103

B. DRAGER JAUNDICE METER JM-105

Reason

Draeger's continuous post market surveillance has shown that some users have concerns about the method used by JM-103 & JM-105 to indicate that a taken measurement is out of range (higher than the measuring range of the device). As described in the instructions for use and in the device's training materials, the JM-103 displays a blinking '- - -' and the JM-105 displays a blinking '- o -' when the measurement is out of range. The measuring range is defined to 340 mol/l / 20 mg/dl.

Affected products