ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
|
Back to Search Results |
|
Lot Number COV3080005 |
Device Problem
Unable to Obtain Readings (1516)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/13/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The current complaint is pending investigation from our contract manufacturer, and we will provide follow up mdr upon investigation completion such as review of batch records or testing of retention samples.Any additional information received by acon may be provided to fda in a follow up mdr.
|
|
Event Description
|
Invalid result (s).We got a call from a customer that is having an issue with a flowflex covid 19 antigen test kits.The customer just purchased the kit from cvs pharmacy, so this is an out of box issue.When the customer performed the test correctly, nothing appeared in the result window.The test window was blank, nothing next to the c-line or t-line.Customer performed the test correctly with 4 drops of the buffer solution and waited 15 minutes.The could not send a picture of the test cassette at this time.I advised the customer that i will be forwarding the information to the complaint team for review.Customer will await an email back from acon labs.
|
|
Manufacturer Narrative
|
Final product manufacture and qc record for (b)(6).No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The test results of retention samples from (b)(6)can meet the qc criteria.We have not found the complaint issue from the retained cassettes.The complaint is not verified.In this follow-up report, the following information has been updated from the initial report upon completion of the internal investigation.The following fields are updated: b4, "date of this report" - date of follow-up report g6, "type of report" - follow-up #1 h2, "if follow-up, what type?" - updated to "additional information" and "device evaluation" h6 "adverse event problem" - event problem and evaluation codes such as "investigation findings" and "investigation conclusions" are added per investigation.H10 "additional narrative/data" - added manufacturer's narrative.
|
|
Event Description
|
Invalid result (s).We got a call from a customer that is having an issue with a flowflex covid 19 antigen test kits.The customer just purchased the kit from cvs pharmacy, so this is an out of box issue.When the customer performed the test correctly, nothing appeared in the result window.The test window was blank, nothing next to the c-line or t-line.Customer performed the test correctly with 4 drops of the buffer solution and waited 15 minutes.The could not send a picture of the test cassette at this time.I advised the customer that i will be forwarding the information to the complaint team for review.Customer will await an email back from acon labs.
|
|
Search Alerts/Recalls
|
|
|