MalfunctionMKZ
BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK
Received Feb 24, 2026 · Event occurred Jan 21, 2026
Report 1119779-2026-00255 · MDR key 24433794
Device
Generic name
Chlamydia Trachomatis Nucleic Acid Ivd, Kit, Nucleic Acid Technique (nat)
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
442959
Lot number
4317407
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E.1: (B)(6). 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 THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLES WAS RE-RUN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.