Corrective action for Testosterone Direct RIA Kit, Beckman Coulter
2007.10.30
Product group In-vitro diagnostics
Reference 03718/07
Corrective action of Beckman Coulter for the Testosterone Direct RIA Kit (lot numbers 225C, 226B, 227B, 227C, 227D, 228B, 228C, 229B, 230B, 231A, 231B, 232B, 233A, 233B, 233C, 234B, 235B, 236B, 237A, 237AB, 237B, 238B, 239B, 240A, 240B, 240C, 241A, 241AB, 241B, 241C, 242B, 243A, 243B, 244B, 244C, 245B, 245C, 246B, 247B, 247C, 248A, 248B, 249B, 250B, 250C, 250D, 251B, 251C, 251D, 252C, 253A, 253B and 253C) because of falsely high results at low analyte concentrations. Customers were informed about the problems and how to avoid it.
Corrective action for Testosterone Direct RIA Kit, Beckman Coulter , Download_VeroeffentlichtAm_EN