FDA Class 1 Recall … most serious type of recall

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Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results​

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product​

  • Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration))
  • Lot codes:
    • 25T (25 tests per box) - U2101750, U2101751, X2006004, X2008001, X2008010, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, X2011005, X2011006, X2011007, X2011008, X2011009, X2011012, X2011013, X2011015, X2011016, X2011017, X2011025, X2011051, X2011052, X2012001, X2012002, X2012004, X2012005, X2012008, X2101002, X2101004, X2101014, X2101031, X2101038
    • 3T (3 tests per box) - U2102003, X2012310
    • 7T (7 tests per box) - U2101748, U2102001, U2102002, X2012711, X2103792
  • Manufacturing Dates: September 1, 2020 to March 3, 2021
  • Distribution Dates: November 2, 2020 to March 22, 2021
  • Devices Recalled in the U.S.: At least 77,339
  • Date Initiated by Firm: March 24, 2021
 

jon forte

Active Member
Feb 19, 2021
117
131
43

Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results​

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product​

  • Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration))
  • Lot codes:
    • 25T (25 tests per box) - U2101750, U2101751, X2006004, X2008001, X2008010, X2009002, X2009004, X2009013, X2009016, X2010004, X2010010, X2011005, X2011006, X2011007, X2011008, X2011009, X2011012, X2011013, X2011015, X2011016, X2011017, X2011025, X2011051, X2011052, X2012001, X2012002, X2012004, X2012005, X2012008, X2101002, X2101004, X2101014, X2101031, X2101038
    • 3T (3 tests per box) - U2102003, X2012310
    • 7T (7 tests per box) - U2101748, U2102001, U2102002, X2012711, X2103792
  • Manufacturing Dates: September 1, 2020 to March 3, 2021
  • Distribution Dates: November 2, 2020 to March 22, 2021
  • Devices Recalled in the U.S.: At least 77,339
  • Date Initiated by Firm: March 24, 2021
🤡🌎
 

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