BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK
Received Feb 23, 2026 · Event occurred Jan 14, 2026
Report 1119779-2026-00252 · MDR key 24415519
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
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK, AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. POSITIVE SAMPLES WERE RE-RAN ON BD VIPER¿ LT SYSTEM, BUT THE NEGATIVE CONTROL FAILED. THERE WAS NO REPORT OF PATIENT IMPACT.
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.