Gen-Probe

Country not established

Devices: 64
FDA recalls: 6

What Gen-Probe makes

Gen-Probe develops molecular diagnostic tests for infectious disease detection, including nucleic acid amplification assays for *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and *Mycoplasma pneumoniae*, as well as culture-based probes for *Mycobacterium tuberculosis*, *Mycobacterium gordonae*, *Haemophilus influenzae*, and *Cryptococcus neoformans*. Their portfolio also includes rapid detection systems for respiratory pathogens and confirmatory assays for gonorrhea.

The company’s diagnostic devices are authorised under US FDA regulations, with most classified as Class I or Class II. Products are listed via the 510(k) and PMA pathways, reflecting their regulatory compliance for in vitro diagnostic use in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue64

Newest first, rows 51-64 of 64

Search and filter all 64 devices

Accupace Group A Streptococcus Id Test Ref K915852

Active Regimes: 510(k) Registry: 510(k) Class:I
Gen-Probe Pal Luminometer Ref K903911

Active Regimes: 510(k) Registry: 510(k) Class:I
Accuprobe Neisseria Gonorrhoeae Culture Confirma. Ref K895583

Active Regimes: 510(k) Registry: 510(k) Class:II
Gen-Probe Aptima Assay For Chlamydia Trachomatis, Model 1088 Ref K053446

Active Regimes: 510(k) Registry: 510(k) Class:I
Accuprobe Streptococcus Pneumoniae Culture Confir. Ref K902908

Active Regimes: 510(k) Registry: 510(k) Class:I
Accuprobe Mycobacterium Intracellulare Culture Ref K897077

Active Regimes: 510(k) Registry: 510(k) Class:I
Gen-Probe Beta-Lactamase Test Kit Ref K870422

Active Regimes: 510(k) Registry: 510(k) Class:I
Legionella Culture Confirmatin Kit Ref K851271

Active Regimes: 510(k) Registry: 510(k) Class:II
Gen-Probe (R) Luminometer - Leader (Tm) Ref K872219

Active Regimes: 510(k) Registry: 510(k) Class:I
Accuprobe Group B Streptococcus Culture Confirma. Ref K894711

Active Regimes: 510(k) Registry: 510(k) Class:I
Accuprobe Histoplasma Capsulatum Culture Conf.test Ref K896859

Active Regimes: 510(k) Registry: 510(k) Class:II
Accuprobe Mycobacterium Avium Culture Test Ref K896494

Active Regimes: 510(k) Registry: 510(k) Class:I
Gen-Probe(R) Amplified Mycobacterium Tuberculosis Direct Test (Mtd Test) Ref P940034

Active Regimes: PMA Registry: PMA Class:II
Aptima Hcv Rna Qualitative Assay Ref P020011

Active Regimes: PMA Registry: PMA Class:II

Rows 51-64 of 64

Showing 51-64 of 64

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 6 recalls initiated by Gen-Probe, the earliest on 2004-06-11 and the most recent on 2014-04-17. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

2014
- 17 Apr 2014 Z-1793-2014 Class III Terminated Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens." Distribution: Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and…
  Full distribution text
  Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).
  Submission number: K003395
2008
- 30 Dec 2008 Z-1436-2011 Unclassified (pre-2012) Terminated This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results. Distribution: Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong…
  Full distribution text
  Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
  Submission number: K974572
- 30 Dec 2008 Z-1437-2011 Unclassified (pre-2012) Terminated This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results. Distribution: Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong…
  Full distribution text
  Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
  Submission number: K921435
- 30 Dec 2008 Z-1438-2011 Unclassified (pre-2012) Terminated This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results. Distribution: Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong…
  Full distribution text
  Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
  Submission number: K896493
2007
- 2 May 2007 Z-0145-2008 Unclassified (pre-2012) Terminated Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches Distribution: Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT Submission number: K974572
2004
- 11 Jun 2004 Z-1072-04 Unclassified (pre-2012) Terminated Reduced stability

What Gen-Probe makes

Catalogue64

Accupace Group A Streptococcus Id Test Ref K915852

Gen-Probe Pal Luminometer Ref K903911

Accuprobe Neisseria Gonorrhoeae Culture Confirma. Ref K895583

Gen-Probe Aptima Assay For Chlamydia Trachomatis, Model 1088 Ref K053446

Accuprobe Streptococcus Pneumoniae Culture Confir. Ref K902908

Accuprobe Mycobacterium Intracellulare Culture Ref K897077

Gen-Probe Beta-Lactamase Test Kit Ref K870422

Legionella Culture Confirmatin Kit Ref K851271

Gen-Probe (R) Luminometer - Leader (Tm) Ref K872219

Accuprobe Group B Streptococcus Culture Confirma. Ref K894711

Accuprobe Histoplasma Capsulatum Culture Conf.test Ref K896859

Accuprobe Mycobacterium Avium Culture Test Ref K896494

Gen-Probe(R) Amplified Mycobacterium Tuberculosis Direct Test (Mtd Test) Ref P940034

Aptima Hcv Rna Qualitative Assay Ref P020011

FDA recalls6