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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 KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Catalog Number 195-000
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2024
Event Type  malfunction  
Event Description
The customer reported six (6) false positive results with the binax now covid-19 ag card kit for six tests performed from (b)(6) 2024 on a nasal sample.This mfr.Report addresses test three (3) of six (6).Confirmation pcr testing (platform - unknown) was performed at the nevada state health laboratory which generated negative result.The customer stated that they always collect two samples, and one is always sent for confirmation test.The customer stated the patient that tested positive were isolated.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
 
Manufacturer Narrative
D4 udi: (b)(4).The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use, device discarded.
 
Event Description
The customer reported six (6) false positive results with the binax now covid-19 ag card kit for six tests performed from (b)(6) 2024 on a nasal sample.This mfr.Report addresses test three (3) of six (6).Confirmation pcr testing (platform - unknown) was performed at the nevada state health laboratory which generated negative result.The customer stated that they always collect two samples, and one is always sent for confirmation test.The customer stated the patient that tested positive were isolated.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
 
Manufacturer Narrative
D4 udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227447y2 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-000 / lot 227447y2, test base part number 195-430h/ lot 223591.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 227447y2 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.
 
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Brand Name
BINAX NOW COVID-19 AG CARD KIT 40T EUA
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 Key18658745
MDR Text Key334748623
Report Number1221359-2024-00148
Device Sequence Number1
Product Code QKP
UDI-Device Identifier10811877011290
UDI-Public10811877011290
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number195-000
Device Lot Number227447Y2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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