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Siemens Healthcare Diagnostics, Inc Recall 88768

Description: ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

Siemens Healthcare Diagnostics, Inc Recall 88768 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0196-2022
Event ID88768
Event DescriptionADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Product TypeDevices
DistributionUS Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Quantity261 kits
Recall ReasonData provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Device Classification20211110
Device Code InfoLot # 44990001, Exp. Date 2021-10-07, UDI # (01)00630414611747(10)44990001(17)20211007. Lot # 60408003, Exp. Date 2021-11-12, UDI # (01)00630414611747(10)60408003(17)20211112.
Center Classification Date20211103
Recall Initiation Date20210922
Recalling FirmSiemens Healthcare Diagnostics, Inc
Initial Notification Letter
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