Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443
Recalled Product
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Hazard / Issue
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Issued by
FDA
Distribution: Nationwide (United States)
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
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