Corrective Action of Siemens Healthcare Diagnostics Inc. for Assayed Chemistry Controls 1 and 2 of ADVIA Chemistry Systems
2008.11.03
Product group In-vitro diagnostics
Reference 03918/08
Corrective Action of Siemens Healthcare Diagnostics Inc. for Assayed Chemistry Controls 1 and 2 of ADVIA Chemistry Systems (Control 1: Lots 197279, 113634, REF 05788372, PN T03-1220-62 and Control 2: Lots 197289, 113637, REF 00944686, PN T03-1221-62) for the Direct Bilirubin-2 (DBIL-2) Component because of reduced reconstituted stability claim. The customers were informed about the problem and how to avoid it.