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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT FLU A+B 30 TEST PHYSICIAN VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT FLU A+B 30 TEST PHYSICIAN VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS Back to Search Results
Model Number 256045
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using kit flu a+b 30 test physician veritor false positive results were obtained by the laboratory personnel.An asan test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "after incubation time, 4 lines were appeared on the cartridge, and veritor plus analysis gave positive results.Customer ran 2nd times with same sample on another bd veritor flu a/b cartridge and compare to a competitor flu a/ bd trip (asan).".
 
Manufacturer Narrative
H6: investigation summary this statement is to summarize the investigation results regarding your complaint that alleges false positive or discrepant results when using kit flu a+b 30 test physician veritor (material # 256045), batch number 0111862.Bd quality performs a systematic approach to investigate false positive or discrepant results complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.The reported issue was unable to be confirmed.The returned photographic provided confirms with the report of false positive or discrepant results.No trend against false positive or discrepant results was identified.The root cause could not be identified.Bd quality will continue to closely monitor for trends.See h10.
 
Event Description
It was reported that while using kit flu a+b 30 test physician veritor false positive results were obtained by the laboratory personnel.An asan test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "after incubation time, 4 lines were appeared on the cartridge, and veritor plus analysis gave positive results.Customer ran 2nd times with same sample on another bd veritor flu a/b cartridge and compare to a competitor flu a/ bd trip (asan).".
 
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Brand Name
KIT FLU A+B 30 TEST PHYSICIAN VERITOR
Type of Device
DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12110541
MDR Text Key260105950
Report Number3006948883-2021-00726
Device Sequence Number1
Product Code PSZ
UDI-Device Identifier00382902560456
UDI-Public00382902560456
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K132692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/08/2023
Device Model Number256045
Device Catalogue Number256045
Device Lot Number0111862
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2020
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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