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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195160
Device Problem Improper Chemical Reaction (2952)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 11/14/2021
Event Type  Injury  
Event Description
The user reported an allergic reaction with the binaxnow¿ covid-19 antigen self test performed (b)(6) 2021. The user reported that after 3 hours of doing the test, he started to experience a runny nose and a headache which lasted the whole night of (b)(6) and the whole day the next day. The user took a nasal saline wash to stop it. The user refused to call a doctor. No medical treatment was provided.
 
Manufacturer Narrative
Technical service advised the user to seek medical care and provided them with the customer with the sds for the nasal swabs. The investigation is still in progress. A supplemental report will be provided after completion.
 
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Brand NameBINAX NOW COVID-19 AG CARD
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough,
ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
MDR Report Key13007142
MDR Text Key282839677
Report Number1221359-2021-03728
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081722030710160341
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2022
Device Catalogue Number195160
Device Lot Number160341
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
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