KIT RSV 30 TEST PHYSICIAN VERITOR
Received Aug 11, 2023 · Event occurred Jul 12, 2023
Report 3014704491-2023-00444 · MDR key 17507412
Device
Generic name
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Catalog number
256038
Lot number
1294669
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT KIT RSV 30 TEST PHYSICIAN VERITOR DISCREPANT RESULTS COMPARED TO PCR RESULTS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN THE RESULTS OF RAPID RESPIRATORY VIRUS TESTS (RSV AND FLU) VERSUS THE PCR RESULTS PERFORMED BY BD MAX. RAPID TESTS WERE PERFORMED ON NASOPHARYNGEAL SWABS. FOR VSR, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 1294669 AND EXPIRATION DATE: 09-20-2024. FOR FLU, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 2292271 AND EXPIRATION DATE: 10-12-2025. PCR WAS PERFORMED ON NASOPHARYNGEAL ASPIRATES USING THE BD MAX SARS-COV2/FLU KIT, LOT 2270730 AND EXPIRATION DATE: 05-12/2023.
Additional Manufacturer Narrative
INITIAL REPORTER PHONE: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER WHICH INDICATED THAT THE DEVICE PERFORMED AS INTENDED; THEY ARE NO LONGER ALLEGING ANY DEFECT WITH THE PRODUCT. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THE PREVIOUS MFR REPORT #3014704491-2023-00444 SHOULD BE CONSIDERED CANCELLED.
Description of Event or Problem
IT WAS REPORTED THAT KIT RSV 30 TEST PHYSICIAN VERITOR DISCREPANT RESULTS COMPARED TO PCR RESULTS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN THE RESULTS OF RAPID RESPIRATORY VIRUS TESTS (RSV AND FLU) VERSUS THE PCR RESULTS PERFORMED BY BD MAX. RAPID TESTS WERE PERFORMED ON NASOPHARYNGEAL SWABS. FOR VSR, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 1294669 AND EXPIRATION DATE: 09-20-2024. FOR FLU, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 2292271 AND EXPIRATION DATE: 10-12-2025. PCR WAS PERFORMED ON NASOPHARYNGEAL ASPIRATES USING THE BD MAX SARS-COV2/FLU KIT, LOT 2270730 AND EXPIRATION DATE: 05-12/2023.