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Siemens Healthcare Diagnostics, Inc. Recall 89953

Description: ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots

Siemens Healthcare Diagnostics, Inc. Recall 89953 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1024-2022
Event ID89953
Event DescriptionADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.
Quantity952 units
Recall ReasonFalsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Device Classification20220511
Device Code InfoAll lot numbers UDI: (01)00630414574646(10)14530079(17)20220304 (01)00630414574646(10)53553079(17)20220304 (01)00630414574646(10)54118081(17)20220521 (01)00630414574646(10)62860081(17)20220521 (01)00630414574646(10)70552083(17)20220805 (01)00630414574646(10)76807076(17)20220115 (01)00630414574646(10)93281076(17)20220115
Center Classification Date20220429
Recall Initiation Date20220303
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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