MalfunctionQEP
BD MAX¿ CTGCTV2 (US)
Received Apr 14, 2026 · Event occurred Mar 25, 2026
Report 3007420875-2026-00087 · MDR key 24871201
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd Kit
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
445435
Lot number
5294863
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 TEST WAS TV POSITIVE. REPEAT TEST WAS TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.