BD MAX¿ CTGCTV2
Received Apr 14, 2026 · Event occurred Mar 19, 2026
Report 3007420875-2026-00089 · MDR key 24872505
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd Kit
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443979
Lot number
5266691
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP. 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 FALSE NEGATIVE CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. URINE SAMPLE WAS CT POSITIVE; HOWEVER, SWAB SAMPLE WAS CT NEGATIVE. UPON REPEAT TESTING ONCE WITH URINE AND TWICE WITH SWAB, ALL WERE CT POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.