BD MAX¿ CTGCTV2 (US)
Received Apr 23, 2026 · Event occurred Mar 23, 2026
Report 3007420875-2026-00103 · MDR key 24965773
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd Kit
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443904
Lot number
5224008
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL RESULT WAS TV POSITIVE. TEST WAS REPEATED AND WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A TRICHOMONAS VAGINALIS (TV) DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL RESULT WAS TV POSITIVE. TEST WAS REPEATED AND WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: INTRODUCTION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT (REF. (B)(4)) FROM LOT 5224008 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. BATCH HISTORY REVIEW: THE REVIEW OF QUALITY CONTROL RECORDS OF BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 5224008 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. INVESTIGATIONAL TESTING: CUSTOMER COMPLAINED ABOUT DISCREPANT RESULTS FOR T. VAGINALIS (TV) TARGET WITH THE BD CTGCTV2 FOR BD MAX¿ SYSTEM. THE INITIAL TEST (RUN #2383/B9) GAVE A POSITIVE RESULT FOR THE TV TARGET, WHILE REPEAT TESTS GAVE UNRESOLVED (UNR, IN RUN #2388/A12) AND NEGATIVE RESULTS (RUN #2390/A1) RESPECTIVELY. CUSTOMER PROVIDED RUNS #2383, 2388 AND 2390 FROM BD MAX¿ INSTRUMENT CT2473 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION REVEALED LATE AND LOW AMPLIFICATION IN THE CY5 CHANNEL (TV TARGET) FOR SAMPLE B9 IN RUN 2383. SUCH A LOW POSITIVE SAMPLE CAN OCCUR DUE TO BACTERIAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. SAMPLES A12 (RUN 2388) AND A1 (RUN 2390) WERE ADDRESSED IN A PREVIOUS COMPLAINT. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD CTGCTV2 FOR BD MAX¿ SYSTEM KIT LOT 5224008. CONCLUSION: THE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), IS THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD WAS IDENTIFIED.