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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM Back to Search Results
Catalog Number 256082
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Information (3190)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
Eua # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported while testing for sars-cov-2 a potential discrepant result was obtained.The cartridge visually showed 3 lines instead of 2 that they see for positive patients.Cartridge inserted into veritor and result was positive.There was no report of patient impact.Eua # (b)(4).
 
Event Description
It was reported while testing for sars-cov-2 a potential discrepant result was obtained.The cartridge visually showed 3 lines instead of 2 that they see for positive patients.Cartridge inserted into veritor and result was positive.There was no report of patient impact.Eua # (b)(6).
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# (b)(4).Was sent in error.Customer was not claiming a false result, they were wanting to know if test was valid with the 3rd line, which is the negative control line on the cartridge, therefore, this is not considered to be a reportable malfunction.
 
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Brand Name
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Type of Device
CORONAVIRUS ANTIGEN DETECTION SYSTEM
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH 
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH  
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11382106
MDR Text Key247514084
Report Number3006948883-2021-00262
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2021
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 Other
Device Expiration Date05/22/2021
Device Catalogue Number256082
Device Lot Number0339952
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/25/2021
Supplement Dates Manufacturer Received11/24/2021
Supplement Dates FDA Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2020
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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