ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur CA 125II Assay (catalog numbers 09427226 and 01678114) because some patient samples may show over-recovery results when diluted that fall outside the ranges provided in the assay instructions for use. The recall affects 13,257 single-pack kits and 9,930 five-pack kits distributed nationwide in the United States and internationally to numerous countries. The affected lots expire in April or August 2018 and are identified by specific lot numbers and Universal Device Identifiers (UDIs) listed in the recall notice.
The recall document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Reason for recall: Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. Distribution: US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Quantity: SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits Lot/code info: SMN 10310443 (1-pack/100 tests): Lot 71804174, Exp 2018-Apr-27, UDI (01)00630414461298(10)71804174(17)20180427 Lot 73838174, Exp 2018-Apr-27, UDI (01)00630414461298(10)73838174(17)20180427 Lot 88601174, Exp 2018-Apr-27, UDI (01)00630414461298(10)88601174(17)20180427 Lot 94549174, Exp 2018-Apr-27, UDI (01)00630414461298(10)94549174(17)20180427 Lot 23904176, Exp 2018-Aug-30, UDI (01)00630414461298(10)23904176(17)20180830 Lot 24439176, Exp 2018-Aug-30, UDI (01)00630414461298(10)24439176(17)20180830 Lot 31842176, Exp 2018-Aug-30, UDI (01)00630414461298(10)31842176(17)20180830 Lot 42051176, Exp 2018-Aug-30, UDI (01)00630414461298(10)42051176(17)20180830 Lot 54008176, Exp 2018-Aug-30, UDI (01)00630414461298(10)54008176(17)20180830 SMN 10315696 (5-pack/500 tests): Lot 71229174, Exp 2018-Apr-27, UDI (01)00630414461304(10)71229174(17)20180427 Lot 73455174, Exp 2018-Apr-27, UDI (01)00630414461304(10)73455174(17)20180427 Lot 84113174, Exp 2018-Apr-27, UDI (01)00630414461304(10)84113174(17)20180427 Lot 91568174, Exp 2018-Apr-27, UDI (01)00630414461304(10)91568174(17)20180427 Lot 23903176, Exp 2018-Aug-30, UDI (01)00630414461304(10)23903176(17)20180830 Lot 24944176, Exp 2018-Aug-30, UDI (01)00630414461304(10)24944176(17)20180830 Lot 41442176, Exp 2018-Aug-30, UDI (01)00630414461304(10)41442176(17)20180830 Lot 46735176, Exp 2018-Aug-30, UDI (01)00630414461304(10)46735176(17)20180830
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.