FDA Adverse Event
Malfunction
Summary report: N
BD MAX¿ CTGCTV2
MDR report key: 24956293
·
Received April 22, 2026
Report
- Report Number
- 3007420875-2026-00102
- Event Type
- Malfunction
- Date Received
- April 22, 2026
- Date of Event
- March 25, 2026
- Report Date
- May 26, 2026
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- LSL
- UDI-DI
- 00382904439064
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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. THIS IS REPORT 10 OF 10.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53245 | BD MAX¿ CTGCTV2 | MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT | LSL | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 5262904 | 00382904439064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |