Bordetella Pertussis Dna Assay System
Microbiology · 21 CFR 866.3980
A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Ortho-Clinical Diagnostics, Inc.Open, ClassifiedJun 11, 2025
Brand Name: Solana Bordetella Complete Assay
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
Z-1948-2025 · View FDA record ↗ - Luminex CorporationOpen, ClassifiedAug 15, 2019
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Z-2282-2019 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Applied Biocode, Inc.
Santa Fe Springs, CA, US
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Diamond Diagnostics Inc
Holliston, MA, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
Luminex Corporation
AUSTIN, TX, US
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Roche Molecular Systems, Inc.
PLEASANTON, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Biogx
Birmingham, AL, US
Luminex Corporation
Northbrook, IL, US
Biofire Diagnostics, Llc
Salt Lake City, UT, US
Diasorin Molecular Llc
CYPRESS, CA, US
Biofire Defense, Llc
Salt Lake City, UT, US
510(k) clearances
9 clearances for this product code
- Roche Molecular Systems, Inc.Nov 20, 2025
K243753 · cobas liat Bordetella panel nucleic acid test
- Diasorin Molecular, LLCDec 19, 2018
K183223 · Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- Diasorin Molecular, LLCAug 13, 2018
K173498 · Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- Quidel CorporationJul 15, 2018
K181029 · Solana Bordetella Complete Assay
- Luminex CorporationMay 2, 2017
K163626 · ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- Great Basin Scientific, Inc.Mar 31, 2017
K170284 · Great Basin Bordetella Direct Test
- Meridian Bioscience, Inc.Nov 10, 2015
K152285 · illumigene Pertussis DNA Amplification Assay
- Quidel CorporationDec 10, 2014
K143206 · AmpliVue Bordetella Assay