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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST
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ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 01/19/2024
Event Type  malfunction  
Event Description
An anonymous consumer direct messaged orasure's instagram page on 01/19/2024 to inquire about false positive test results.The consumer stated a handful of them have gotten faint positives but tested negative on other inteliswab, ihealth, and lucira tests.The consumer added that someone also got a negative pcr test.It is unknown how many individuals and inteliswab tests were involved.On 02/02/2024, oti marketing department replied to the consumer's direct message advising they email oti so we can reach out to them directly for additional information.Refer to attached screenshot of the instagram dm conversation.
 
Manufacturer Narrative
The consumer direct messaged oti's instagram reporting multiple false positive inteliswab test results among multiple users.The consumer did not provide details of how the tests were performed or if the ifu was followed.Oti marketing responded to the consumer's facebook comment advising them to email more information to technicalservice@orasure.Com.The consumer has not provided a lot number or any additional information to date.No additional follow up is to be expected with this complaint and the incident will be closed internally.
 
Event Description
An anonymous consumer direct messaged orasure's instagram page on 01/19/2024 to inquire about false positive test results.The consumer stated a handful of them have gotten faint positives but tested negative on other inteliswab, ihealth, and lucira tests.The consumer added that someone also got a negative pcr test.It is unknown how many individuals and inteliswab tests were involved.On 02/02/2024, oti marketing department replied to the consumer's direct message advising they email oti so we can reach out to them directly for additional information.Refer to attached screenshot of the instagram dm conversation.
 
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Brand Name
INTELISWAB COVID-19 RAPID TEST
Type of Device
INTELISWAB
Manufacturer (Section D)
ORASURE TECHNOLOGIES, INC.
220 east first street
bethlehem PA 18015
Manufacturer (Section G)
ORASURE TECHNOLOGIES, INC.
220 east first street
bethlehem PA 18015
Manufacturer Contact
jennifer krause
220 east first street
bethlehem, PA 18015
6108821820
MDR Report Key18650504
MDR Text Key334884279
Report Number3004142665-2024-00002
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
EUA210378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/20/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/01/2024
Initial Date FDA Received02/06/2024
Supplement Dates Manufacturer Received02/01/2024
Supplement Dates FDA Received02/20/2024
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 Unknown
Patient Sequence Number1
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