Important Safety Alerts

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