Corrective action for Siemens N Latex CDT Kit, Siemens Healthcare Diagnostics
2008.05.09
Product group In-vitro diagnostics
Reference 01502/08
Corrective action of Dade Behring Marburg GmbH (Siemens Healthcare Diagnostics) for Siemens N Latex CDT Kit (OPCS03), Lot Numbers 37906, 37825, 37811, 37750, 37636, 37621, 37440, 37333, 37229, 37055, 37022 (OUS) and N Latex CDT Kit (OPCS05), Lot Numbers 37892, 37810, 37023 (US) because of negative bias observed in %CDT values. Due to the observed decrease in results, the sensitivity of N Latex CDT versus HPLC is reduced. The customers were informed about the problem and how to avoid it.