| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00325-1 |
| Product Name/Description |
Dräger Jaundice Meters
Models Numbers: JM-103 and JM-105
ARTG Number: 152624
Draeger Australia - Analyser, bilirubinometer |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Draeger has determined through Post Market Surveillance activities that some users have concerns about the method used by the JM-103 and JM-105 to indicate that a taken measurement is out of range (higher than the measuring range of the device). Uncertainty about high value indication may result in delayed treatment of a patient with hyperbilirubinemia.
As described in the Instructions for Use Manual and in the device's training materials:
- Jaundice Meter model JM-103 displays a blinking "- - -" when the measurement is out of range. The measuring range is defined to 340 µmol/L; and
- Jaundice Meter model JM-105 displays a blinking "- 0 -" when the measurement is out of range. The measuring range is defined to 340 µmol/L. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Draeger is providing users with stickers to adhere to JM-103 and JM-105 devices to re-enforce the meaning of the associated blinking units "---" for JM-103 and "-0-" for JM-105 when the measurement is higher than the measuring range of the device.
Users are to refer to the instructions provided on the Customer Letter for correct location for the stickers.
This action has been superseeded by RC-2018-RN-01493-1. |
| Contact Information |
03 9244 7248 - Draeger |