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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Catalog Number 195-160
Device Problem Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Manufacturer Narrative
The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.Single use; device discarded.
 
Event Description
The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on (b)(6) 2024 on nasal samples.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Additional testing was performed on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024 with binaxnow covid-19 antigen self-test kits, all generating negative results.The consumer indicated they were experiencing symptoms on (b)(6) 2024 such as a slight sore throat but this symptom only lasted one (1) day.As of (b)(6) 2024, the consumer is no longer experiencing symptoms and feels fine.The consumer confirmed there was no harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in treatment.
 
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Brand Name
BINAXNOW COVID-19 AG SELF TEST 2CT
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key18943646
MDR Text Key338586714
Report Number1221359-2024-00287
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public00811877011408
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number195-160
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received03/20/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age61 YR
Patient SexFemale
Patient Weight66 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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