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Recall Observatory FDA recall evidence

Device product

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

Z-0195-2022

September 22, 2021

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 88768
Status
Terminated
Classification
Class II
Quantity
149 kits
Official record key
device-enforcement:Z-0195-2022

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 # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(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.