GENBODY COVID-19 AG COVAG025-N
Report
- Report Number
- MW5107404
- Event Type
- Malfunction
- Date Received
- February 11, 2022
- Report Date
- February 9, 2022
- Manufacturer
- GENBODY INC.
- Product Code
- QKP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- N
Narratives
[GENBODY COVID-19 AG] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): (B)(6) 2022, TO: (B)(6), CC: CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) AND OFFICE OF PRODUCT EVALUATION AND QUALITY (OPEQ); DR. (B)(6), RE: CERTAIN ANTIGEN IN VITRO DIAGNOSTICS (IVD) FOR DETECTION AND/OR DIAGNOSIS OF SARS-COV-2, THE VIRUS THAT CAUSES COVID-19 WE ARE WRITING TO MAKE YOU AWARE OF INFORMATION THAT COULD IMPACT THE USE OF ANTIGEN TESTS. ON (B)(6) 2022, (B)(6) PROACTIVELY AND TEMPORARILY PAUSED THE USE OF ALL RAPID ANTIGEN TESTS AT OUR PUBLIC TESTING SITES NATIONWIDE. AS EXPLAINED IN MORE DETAIL BELOW, THIS CHANGE COMES OUT OF AN ABUNDANCE OF CAUTION RELATED TO ANOMALIES WE IDENTIFIED IN THE PERFORMANCE OF SEVERAL EUA-AUTHORIZED ANTIGEN TESTS. AS NATIONAL LEADERS IN COMMUNITY COVID-19 CARE SINCE THE BEGINNING OF THE PANDEMIC, (B)(6) HAS SERVED MILLIONS OF AMERICANS WITH EASY-TO-ACCESS TESTING ACROSS MORE THAN 200 CARE SITES. WE ARE POWERED BY A NETWORK OF CLIA-CERTIFIED MOLECULAR LABS, AND WE SPECIALIZE IN REACHING UNDERSERVED POPULATIONS WITHIN JAILS, PUBLIC HOUSING, LONG-TERM CARE FACILITIES AND MORE. WE TAKE SERIOUSLY OUR ROLE AS STEWARDS OF PUBLIC HEALTH. IN OUR LATEST ANALYSIS BASED ON AN ANONYMIZED DATA SET OF 1.4 MILLION TEST RESULTS SPANNING THE PAST EIGHT WEEKS, OUR TEAM OF CLINICAL LEADERS NOTED AN UNEXPECTED ANOMALY IN RESULTS FOR PATIENTS WHO HAD POLYMERASE CHAIN REACTION (PCR) AND ANTIGEN TESTS ON THE SAME DAY, SPECIFICALLY AS IT RELATES TO THE RATES OF FALSE NEGATIVES ACROSS MULTIPLE ANTIGEN TEST PROVIDERS. WE RESPECTFULLY BELIEVE THIS DISCREPANCY WARRANTS FURTHER REVIEW NOT JUST BY (B)(6) BUT IN CONCERT WITH FDA OFFICIALS AND OUR PARTNERS AT THE STATE LEVEL. WE BELIEVE THE RESULTS ARE SIGNIFICANT ENOUGH THAT WE HAVE TEMPORARILY PAUSED THE USE OF SPECIFIC POINT-OF-CARE RAPID ANTIGEN TESTS UNTIL WE BETTER UNDERSTAND OUR FINDINGS REGARDING THE USE OF RAPID ANTIGEN TESTS. ALL (B)(6) COMMUNITY SITES ARE READY AND EQUIPPED TO CONTINUE TO OFFER PATIENTS FDA EUA-AUTHORIZED PCR TESTS, LONG HELD AS THE GOLD STANDARD IN COVID TESTING. WE WELCOME YOUR PERSPECTIVE AND GUIDANCE BASED ON YOUR OFFICE'S ONGOING WORK MONITORING THE PERFORMANCE OF AUTHORIZED ANTIGEN IVDS USED TO DETECT EMERGING SARS-COV-2 MUTATIONS. WE ALSO STAND READY TO SHARE OUR DATA WITH YOU IN YOUR OVERALL ASSESSMENT OF THE EFFICACY OF CERTAIN EUA-AUTHORIZED ANTIGEN TESTS INCLUDING GENBODY COVID-19 AG WE WELCOME FURTHER DIALOGUE BETWEEN FDA AND OUR CLINICAL LEADERSHIP. WE TAKE SERIOUSLY OUR RESPONSIBILITY AS A LEADER IN NATIONAL TESTING, AND WE BRING THIS DATA FORWARD TO HELP ENSURE THAT FDA HAS ACCESS TO TIMELY INFORMATION AND TO HELP ENSURE THE PUBLIC HAS ACCESS TO THE MOST ACCURATE AND RELIABLE TESTING AS WE TRANSITION TO AN ENDEMIC STATE WHERE WE MUST LEARN TO LIVE SAFELY WITH COVID. PLEASE LET ME KNOW IF WE CAN BE OF FURTHER ASSISTANCE. SINCERELY, (B)(6). FDA SAFETY REPORT ID # (B)(4).
ADDITIONAL INFORMATION RECEIVED FOR REPORT MW (B)(4) ON 03/02/2022 FOR MFR.
[GENBODY COVID-19 AG] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): (B)(6) 2022, TO: (B)(6), CC: CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) AND OFFICE OF PRODUCT EVALUATION AND QUALITY (OPEQ); DR. (B)(6), RE: CERTAIN ANTIGEN IN VITRO DIAGNOSTICS (IVD) FOR DETECTION AND/OR DIAGNOSIS OF SARS-COV-2, THE VIRUS THAT CAUSES COVID-19 WE ARE WRITING TO MAKE YOU AWARE OF INFORMATION THAT COULD IMPACT THE USE OF ANTIGEN TESTS. ON (B)(6) 2022, (B)(6) PROACTIVELY AND TEMPORARILY PAUSED THE USE OF ALL RAPID ANTIGEN TESTS AT OUR PUBLIC TESTING SITES NATIONWIDE. AS EXPLAINED IN MORE DETAIL BELOW, THIS CHANGE COMES OUT OF AN ABUNDANCE OF CAUTION RELATED TO ANOMALIES WE IDENTIFIED IN THE PERFORMANCE OF SEVERAL EUA-AUTHORIZED ANTIGEN TESTS. AS NATIONAL LEADERS IN COMMUNITY COVID-19 CARE SINCE THE BEGINNING OF THE PANDEMIC, (B)(6) HAS SERVED MILLIONS OF AMERICANS WITH EASY-TO-ACCESS TESTING ACROSS MORE THAN 200 CARE SITES. WE ARE POWERED BY A NETWORK OF CLIA-CERTIFIED MOLECULAR LABS, AND WE SPECIALIZE IN REACHING UNDERSERVED POPULATIONS WITHIN JAILS, PUBLIC HOUSING, LONG-TERM CARE FACILITIES AND MORE. WE TAKE SERIOUSLY OUR ROLE AS STEWARDS OF PUBLIC HEALTH. IN OUR LATEST ANALYSIS BASED ON AN ANONYMIZED DATA SET OF 1.4 MILLION TEST RESULTS SPANNING THE PAST EIGHT WEEKS, OUR TEAM OF CLINICAL LEADERS NOTED AN UNEXPECTED ANOMALY IN RESULTS FOR PATIENTS WHO HAD POLYMERASE CHAIN REACTION (PCR) AND ANTIGEN TESTS ON THE SAME DAY, SPECIFICALLY AS IT RELATES TO THE RATES OF FALSE NEGATIVES ACROSS MULTIPLE ANTIGEN TEST PROVIDERS. WE RESPECTFULLY BELIEVE THIS DISCREPANCY WARRANTS FURTHER REVIEW NOT JUST BY (B)(6) BUT IN CONCERT WITH FDA OFFICIALS AND OUR PARTNERS AT THE STATE LEVEL. WE BELIEVE THE RESULTS ARE SIGNIFICANT ENOUGH THAT WE HAVE TEMPORARILY PAUSED THE USE OF SPECIFIC POINT-OF-CARE RAPID ANTIGEN TESTS UNTIL WE BETTER UNDERSTAND OUR FINDINGS REGARDING THE USE OF RAPID ANTIGEN TESTS. ALL (B)(6) COMMUNITY SITES ARE READY AND EQUIPPED TO CONTINUE TO OFFER PATIENTS FDA EUA-AUTHORIZED PCR TESTS, LONG HELD AS THE GOLD STANDARD IN COVID TESTING. WE WELCOME YOUR PERSPECTIVE AND GUIDANCE BASED ON YOUR OFFICE'S ONGOING WORK MONITORING THE PERFORMANCE OF AUTHORIZED ANTIGEN IVDS USED TO DETECT EMERGING SARS-COV-2 MUTATIONS. WE ALSO STAND READY TO SHARE OUR DATA WITH YOU IN YOUR OVERALL ASSESSMENT OF THE EFFICACY OF CERTAIN EUA-AUTHORIZED ANTIGEN TESTS INCLUDING GENBODY COVID-19 AG WE WELCOME FURTHER DIALOGUE BETWEEN FDA AND OUR CLINICAL LEADERSHIP. WE TAKE SERIOUSLY OUR RESPONSIBILITY AS A LEADER IN NATIONAL TESTING, AND WE BRING THIS DATA FORWARD TO HELP ENSURE THAT FDA HAS ACCESS TO TIMELY INFORMATION AND TO HELP ENSURE THE PUBLIC HAS ACCESS TO THE MOST ACCURATE AND RELIABLE TESTING AS WE TRANSITION TO AN ENDEMIC STATE WHERE WE MUST LEARN TO LIVE SAFELY WITH COVID. PLEASE LET ME KNOW IF WE CAN BE OF FURTHER ASSISTANCE. SINCERELY, (B)(6). FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1263156 | GENBODY COVID-19 AG COVAG025-N | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM | QKP | GENBODY INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |