Device product
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.
Z-1432-2021
Product summary
- Event
- Event 87541
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)
- Official record key
device-enforcement:Z-1432-2021
Official wording
Reason: Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
Code information: Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada.
Derived failure modes
-
Labeling or packaging
incorrect labeling