FDA Adverse Event
Malfunction
Summary report: N
BD MAX¿ CTGCTV2
MDR report key: 24872505
·
Received April 14, 2026
Report
- Report Number
- 3007420875-2026-00089
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- March 19, 2026
- Report Date
- April 23, 2026
- Manufacturer
- GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
- Product Code
- LSL
- UDI-DI
- 00382904439798
- PMA / PMN Number
- K210585
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP. 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, A FALSE NEGATIVE CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. URINE SAMPLE WAS CT POSITIVE; HOWEVER, SWAB SAMPLE WAS CT NEGATIVE. UPON REPEAT TESTING ONCE WITH URINE AND TWICE WITH SWAB, ALL WERE CT POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602125 | BD MAX¿ CTGCTV2 | MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT | LSL | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) | 5266691 | 00382904439798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |