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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST

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ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST Back to Search Results
Catalog Number RCPM-00279
Device Problem False Negative Result (1225)
Patient Problems Fever (1858); Viral Infection (2248)
Event Date 01/03/2022
Event Type  malfunction  
Event Description
I tested myself twice on the same day having strong symptoms of covid including having a fever. I know i did the test right and it showed negative both times. I knew something wasn't right, so i went to urgent care on the same day, and they tested me, and i was positive for covid. , so this is telling me your on/go test was defective.
 
Manufacturer Narrative
1. Review of device history record (dhr) of cp21k43: dhr of the product was reviewed to examine any deviations during the production. The records demonstrated that the lot was manufactured in accordance with approved standard operating procedures. 2. Review of in-process quality control performance of cp21k43 test record: a total of 800 cassettes were tested against qc panels and all cassettes showed valid results. 3. Retain test of cp21k43: a total of 5 kit boxes (10 cassettes) were tested against qc panels and showed valid results. Additional 5 kit boxes (10 cassettes) were tested at access bio by individuals having no clinical signs, symptoms, conditions. All 10 cassettes showed valid negative results.
 
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Brand NameON/GO COVID-19 ANTIGEN SELF-TEST
Type of DeviceCOVID-19 ANTIGEN SELF-TEST
Manufacturer (Section D)
ACCESS BIO INCORPORATE
65 clyde rd suite a
somerset NJ 08873
Manufacturer Contact
david park
65 clyde rd suite a
somerset, NJ 08873
7328734040
MDR Report Key13536966
MDR Text Key287206876
Report Number3003966368-2022-00002
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Catalogue NumberRCPM-00279
Device Lot NumberCP21K43
Was Device Available for Evaluation? No
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
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