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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
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ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP Back to Search Results
Lot Number COV2020169
Device Problem No Device Output (1435)
Patient Problem Insufficient Information (4580)
Event Date 01/03/2023
Event Type  malfunction  
Event Description
Invalid result (s).We got a call from a customer that is having an issue with a flowflex covid 19 antigen test kit.The customer has just purchased 16 test kts from 2 different cvs stores so this is an out of box issue.When the customer performed 5 kits from the same lot number (cov2020169) he got a faint t-line on each test.Customer performed 5 tests from different lot number (cov2020145 ) and got negative for his results.Both batches of test kits all had the control line show up on all 10 tests he performed.The customer had a pcr test performed as follow up and was negative for covid 19.The customer was upset that he had to purchase the 16 test kits to find out if he had covid 19 or not.The customer is requesting the 10 replacement test kits, because he had to use that many test to find out he was negative.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for an email response from acon labs regarding this matter.Customer provided a picture of 1 test kit form each lot number.The test cassette with the faint t-line in the picture is lot # cov2020169 exp 06/23/2023.
 
Manufacturer Narrative
Final product manufacture and qc record for cov2020169 were reviewed.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 cov2020169 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".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 kit.The customer has just purchased 16 test kts from 2 different cvs stores so this is an out of box issue.When the customer performed 5 kits from the same lot number (cov2020169) he got a faint t-line on each test.Customer performed 5 tests from different lot number (cov2020145 ) and got negative for his results.Both batches of test kits all had the control line show up on all 10 tests he performed.The customer had a pcr test performed as follow up and was negative for covid 19.The customer was upset that he had to purchase the 16 test kits to find out if he had covid 19 or not.The customer is requesting the 10 replacement test kits, because he had to use that many test to find out he was negative.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for an email response from acon labs regarding this matter.Customer provided a picture of 1 test kit form each lot number.The test cassette with the faint t-line in the picture is lot # cov2020169 exp 06/23/2023.
 
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Brand Name
FLOWFLEX COVID-19 ANTIGEN HOME TEST
Type of Device
ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
Manufacturer (Section D)
ACON LABORATORIES, INC.
5850 oberlin drive #340
san diego CA 92121
Manufacturer (Section G)
ACON LABORATORIES, INC.
5850 oberlin drive #340
san diego CA 92121
Manufacturer Contact
qiyi xie
5850 oberlin drive #340
san diego, CA 92121
8588758011
MDR Report Key16398055
MDR Text Key309773366
Report Number2531491-2023-00479
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
EUA210494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/23/2023
Device Lot NumberCOV2020169
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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