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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience
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179 records meeting your search criteria returned- Product Code: QKO Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT 05/04/2022
ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2 S 02/02/2022
ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT 10/20/2021
CURATIVE / ABBOTT DIAGNOSTICS SCARBOROUG COVID TEST / CURATIVE 09/01/2021
Unknown Manufacturer TESTING FOR COVID TITERS, VACCINE 08/31/2021
ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2 08/25/2021
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SARS-COV-2 TOTAL (COV2 08/02/2021
INNOVA MEDICAL GROUP, INC. COVID-19 SELF-TEST (RAPID ANTIGEN TEST) 06/15/2021
INNOVA MEDICAL GROUP, INC. COVID-19 SELF-TEST (RAPID ANTIGEN TEST) 06/15/2021
INNOVA MEDICAL GROUP, INC. COVID-19 SELF-TEST (RAPID ANTIGEN TEST) 06/15/2021
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