• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 140709
Device Problems Shipping Damage or Problem (1570); Expiration Date Error (2528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Event Description
Patient called to report an expiration issue related to binaxnow covid-19 tests he purchased from (b)(6). Patient stated he placed the order for six tests on (b)(6) 2021, received them on (b)(6) 2021, and noticed they had an expiration date of 9-28-2021, which was only 6 days after receiving the tests. Patient said he called the company and was told they would send him more tests. Patient stated he never received more tests so he called again and was told the expiration date could be extended 3 months. Patient said he never did receive replacement tests, and the extended expiration did not help him as he was intending to use them for travel after the 3 month extended expiration date.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBINAXNOW COVID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key12908443
MDR Text Key281583748
Report NumberMW5105674
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/30/2021
6 Devices were Involved in the Event: 1   2   3   4   5   6  
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number140709
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No

-
-