microscan synergies plus and microscan rapid/s panels 의 안전성 경고

Safety alert

2013-09-23

2013-09-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130923a.html

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.