Events

Safety Alert for microscan synergies plus and microscan rapid/s panels

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Siemens Healthcare Diagnostics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-09-23
  • Event Date Posted
    2013-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130923a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: siemens microscan synergies plus and microscan rapid/s panels the united states food and drug administration (fda) has issued a field safety notice concerning microscan synergies plus and microscan rapid/s panels, manufactured by siemens healthcare diagnostics, inc. the affected products are identified as follows:- synergies plus negative urine combo 1- 10444745 / b1025-106 synergies plus negative combo 2 - 10444747 / b1025-108 synergies plus negative breakpoint combo 7 - 10444748 / b1025-109 synergies plus negative urine combo 2 - 10444749 / b1025-112 synergies plus negative urine combo 5 - 10483101 / b1025-115 microscan plus negative combo 3 (sold outside of us only) – 10444600 / b1016-201 microscan plus negative urine combo 4 (sold outside of us only) - 10444601 / b1016-202 microscan plus negative breakpoint combo 4 (sold outside of us only) – 10460272 / b1016-203 microscan rapid/s panels nc3.11 (sold in japan only) - 10444792 / j1025-311 microscan rapid/s panels nc3.12 (sold in japan only) – 10444793 / j1025-312 microscan rapid/s panels nc3.33 (sold in japan only) – 10444794 / j1025-333 this field safety notice has update of affected products, concerning a medical device safety alert previously issued (with links: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm367217.Htm; and http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm368112.Htm). according to this field safety notice, there is confirmed increase in false susceptible and false intermediate misreads for imipenem and/or meropenum on synergies plus negative and rap id/s plus negative panels read on walk away system. for details, please visit the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=66058&w=09182013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2013.

Device

microscan synergies plus and microscan rapid/s panels

Manufacturer

Siemens Healthcare Diagnostics