BD MAX¿ CTGCTV2 (US)
Received Jun 26, 2026 · Event occurred Mar 1, 2024
Report 3007420875-2026-00135 · MDR key 25636248
Device
Generic name
Multiple-type Sexually Transmitted Pathogen Nucleic Acid Ivd Kit
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
443904
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. D.4. MEDICAL DEVICE LOT: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS SENT TO AN EXTERNAL LAB TO BE TESTED ON PANTHER, AND RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.