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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience
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9 records meeting your search criteria returned- Product Code: QKP Product Problem: Inadequate Instructions for Non-Healthcare Professional Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
ABBOTT ABBOTT BINAXNOW COVID ANTIGEN SELF TEST 02/13/2023
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 SELF TEST 01/04/2023
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 08/16/2022
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW 07/15/2022
IHEALTH LABS, INC. COVID-19 ANTIGEN RAPID TEST 06/17/2022
ACON LABORATORIES, INC. FLOWFEX COVID-19 ANTIGEN HOME TEST 06/01/2022
QUIDEL CORP. QUICKVUE AT-HOME OTC COVID-19 TEST 01/12/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 01/11/2022
ABBOTT DIAGNOSTICS SCARBOROUGH INC. ABBOTT BINAXNOW HOME APP 03/02/2021
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