Device product

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

Z-0196-2022

September 22, 2021

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 88768
Status: Terminated
Classification: Class II
Quantity: 261 kits
Official record key: device-enforcement:Z-0196-2022

Official wording

Reason: Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

Code information: Lot # 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.

Distribution pattern: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.