MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK; CHLAMYDIA TRACHOMATIS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE (NAT)

Catalog Number	442959
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
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.

• Brand Name: BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACK
• Common Device Name: CHLAMYDIA TRACHOMATIS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE (NAT)
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24433797
• Report Number: 1119779-2026-00258
• Device Sequence Number: 10303865
• Product Code: MKZ
• UDI-Device Identifier: 00382904429591
• UDI-Public: (01)00382904429591(17)260531(10)4317407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 442959
• Device Lot Number: 4317407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown