Safety Alert Or Field Safety Notices for JM103 and JM105 Jaundice Meters

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

In response to measuring values of bilirubin greater than 340 µmol/l or 20.0 mg/dl, the JM103 will display a flashing “- - -“error message whilst the JM105 will display a flashing “- 0 -“ error message. Misinterpretation of these messages has led to delay of treatment for jaundice in neonates. The manufacturer is supplying information labels to apply to these devices to clarify the meaning of these error messages.The manufacturer will make a firmware upgrade available for JM105 devices that will allow the user to set the error message displayed in these circumstances to “>340 µmol/l” or “>20 mg/dl” or “- 0 -“. Organisations with JM105 devices will be contacted by the manufacturer via a Field Safety Notice to offer this upgrade which will be free of charge for all devices. The MHRA advises that this update is applied and option “- 0 -“ is not used.