Dna Probe, Nucleic Acid Amplification, Chlamydia
Microbiology · 21 CFR 866.3120
Recent MDR events
80 adverse event reports on file
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00256
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00264
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00261
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00263
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00262
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00255
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00259
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00257
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00258
- BD PROBETEC¿ CHLAMYDIA TRACHOMATIS QX ASSAY GRAY AMP REAGENT PACKFeb 24, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-00260
Event type breakdown
Recalls
3 recall events for this product code
- Becton Dickinson & Co.TerminatedJun 24, 2011
BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***
In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.
Z-2658-2011 · View FDA record ↗ - Becton Dickinson & Co.TerminatedMar 3, 2010
BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
Product was shipped beyond its expiration date.
Z-0969-2010 · View FDA record ↗ - Roche Molecular Systems IncTerminatedAug 19, 2004
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.)
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Z-1360-04 · View FDA record ↗
Registered firms
66 firms currently registered for this product code
Becton, Dickinson & Co.
SPARKS, MD, US
Spot Health Inc.
Cincinnati, OH, US
Roche Molecular Systems, Inc.
PLEASANTON, CA, US
Hologic, Inc.
SAN DIEGO, CA, US
Abbott Molecular Distribution Center
Itasca, IL, US
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Abbott Molecular, Inc.
Des Plaines, IL, US
Cepheid
Sunnyvale, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Binx Health, Ltd.
Trowbridge Wiltshire, GB
Hochuen Medical Technology Co.,ltd.
Shenzhen Guangdong, CN
510(k) clearances
19 clearances for this product code
- Hologic, Inc.Nov 16, 2023
K230451 · Aptima® Chlamydia trachomatis Assay
- Becton, Dickinson & COMay 20, 2014
K140446 · BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- Roche Molecular Systems, Inc.Jan 24, 2012
K110923 · COBAS 4800 CT / NG TEST
- Becton, Dickinson & CONov 13, 2009
K091724 · BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
- Becton, Dickinson & COJun 2, 2009
K090824 · BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- Becton, Dickinson & CODec 11, 2008
K081824 · BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
- Abbott Molecular, Inc.Jul 10, 2008
K080739 · ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
- Roche Diagnostics CorporationApr 16, 2007
K070174 · AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY