BD VERITOR ¿ SARS-COV-2 & FLU A+B
Report
- Report Number
- 3006948883-2023-00115
- Event Type
- Malfunction
- Date Received
- November 28, 2023
- Date of Event
- October 18, 2023
- Report Date
- August 14, 2025
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- QMN
- UDI-DI
- 00382902580881
- PMA / PMN Number
- SEE H.10.
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES MIX OF PRODUCT ISSUE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBERS 3193518. THE CUSTOMER REPORTED THAT THEY ORDERED 5 TRIPLEX KITS AND TWO OF THE TRIPLEX KITS CAME WITH COVID ONLY TESTING CARTRIDGES, INSTEAD OF THE TRIPLEX TESTING CARTRIDGES. THE EXTRACTION TUBES WERE THE CORRECT COVID/FLU COMBO, ONLY THE CASSETTES WERE INCORRECT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE MIX OF PRODUCT COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE ANALYSIS WERE PERFORMED ON THE BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. THERE ARE NO RISKS OF PRODUCT MIX IDENTIFIED VIA BHR REVIEW AND RETENTION SAMPLE CHECK. NO PHYSICAL SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THE CUSTOMER SHARED THE PHOTOGRAPHS OF AFFECTED KIT CONFIRMING THAT THEY RECEIVED COVID ONLY CARTRIDGES INSIDE INSTEAD OF THE TRIPLEX TEST CARTRIDGE IN THE TRIPLEX KITS. THIS COMPLAINT WAS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE. BASED ON THE INFORMATION PROVIDED AT THIS MOMENT, NO ROOT CAUSE WAS IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR MIX OF PRODUCT WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B5. DESCRIBE EVENT: IT WAS REPORTED THAT TWO BD VERITOR ¿ SARS-COV-2 & FLU A+B KITS HAD BD VERITOR ¿ SARS-COV-2 CARTRIDGES INSIDE THE BOX. NO PATIENT IMPACT REPORTED. H3 OTHER TEXT : SEE H.10.
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G5: PMA/510(K)#: ITEM IS ALSO EUA :(B)(4).
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED PRIOR TO USING VERITOR ¿ SARS-COV-2 & FLU A+B KITS, THERE WERE INCORRECT CARTRIDGES (BD VERITOR ¿ SARS-COV-2) CONTAINED IN A KIT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING (B)(6) 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED THAT TWO BD VERITOR ¿ SARS-COV-2 & FLU A+B KITS HAD BD VERITOR ¿ SARS-COV-2 CARTRIDGES INSIDE THE BOX. NO PATIENT IMPACT REPORTED.
IT WAS REPORTED THAT 5 BD VERITOR ¿ SARS-COV-2 & FLU A+B KITS HAD BD VERITOR ¿ SARS-COV-2 CARTRIDGES INSIDE THE BOX.
IT WAS REPORTED PRIOR TO USING VERITOR ¿ SARS-COV-2 & FLU A+B KITS, THERE WERE INCORRECT CARTRIDGES (BD VERITOR ¿ SARS-COV-2) CONTAINED IN A KIT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1524108 | BD VERITOR ¿ SARS-COV-2 & FLU A+B | NOT CLASSIFIED | QMN | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | 3193518 | 00382902580881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |