MalfunctionLSL
BD MAX¿ CTGCTV2 (US)
Received May 22, 2026 · Event occurred May 11, 2026
Report 3007420875-2026-00118 · MDR key 25254223
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd Kit
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443904
Lot number
6016413
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 DISCREPANT TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS TV NEGATIVE ON BD MAX¿ CTGCTV2. REPEAT TEST WAS TV POSITIVE ON BD MAX¿ VAGINAL PANEL. THERE WAS NO REPORT OF PATIENT IMPACT.