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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 3649539
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2022
Event Type  malfunction  
Event Description
(b)(6) sold and shipped quidel quickvue at-home otc covid-19 tests. I order 4 boxes and they arrive with the safety seal broken/open the boxes opened and damaged, and the some of the contents moved. I contacted (b)(6) who refused a refund and failed to have a supervisor contact me; instead the offered 4 replacement boxes. The customer service agent said boxes are shipped from stores and warehouses. The replacement boxes also arrived open-- the safety seal deliberately and intentionally opened, the boxes opened, and the some of contents moved around. The mailing envelope is sealed, but someone at (b)(6) or a (b)(6) is deliberately tampering with the at-home covid-19 tests; they could potentially be reselling used tests. I contacted quidel, the manufacturer, who told me that they have been receiving calls about (b)(6) selling opened covid-19 tests. (b)(6) is either engaging in fraud (selling opened and perhaps damaged/used tests and refusing to refund the cost to the consumer), or is exhibiting gross negligence in sending out opened/damaged medical tests; either way this is illegal and contributes to the spread of covid- 19. I have the boxes, the mailing invoices, and the records form contacting (b)(6) is you would like those. Fda safety report id # (b)(4).
 
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Brand NameQUICKVUE AT-HOME OTC COVID-19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORPORATION
MDR Report Key13499486
MDR Text Key285462262
Report NumberMW5107298
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 02/06/2022
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number3649539
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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