MalfunctionLSL
BD MAX¿ CTGCTV2
Received Apr 22, 2026 · Event occurred Mar 25, 2026
Report 3007420875-2026-00091 · MDR key 24953549
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd Kit
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443906
Lot number
5262904
Product problems
- False Positive Result
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, AN UNSPECIFIED NUMBER OF TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULTS WITH UNUSUAL PCR CURVE WERE OBTAINED.POSITIVE SAMPLES WERE REPEATED ON MAX AND WERE 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.