medical Class II Updated 2022-05-11

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagn

Recalled Product

ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots


Hazard / Issue

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers UDI: (01)00630414573342(10)08930076(17)20220115 (01)00630414573342(10)10982085(17)20221108 (01)00630414573342(10)19929072(17)20210819 (01)00630414573342(10)20298079(17)20220304 (01)00630414573342(10)48171081(17)20220304 (01)00630414573342(10)53554081(17)20220521 (01)00630414573342(10)70551083(17)20220805 (01)00630414573342(10)76055076(17)20220115
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