medical Class II Updated 2022-05-11

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnos

Recalled Product

Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 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)00630414598864(10)10054080(17)20220303 (01)00630414598864(10)10979086(17)20221107 (01)00630414598864(10)53378082(17)20220521 (01)00630414598864(10)70532084(17)20220804
View official government recall

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