BD MAX¿ CTGCTV2 (US)
Received Jun 26, 2026 · Event occurred Mar 1, 2024
Report 3007420875-2026-00137 · MDR key 25637167
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
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.
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.