Devices

Device Recall AccuProbe MYCOBACTERIUM TUBERCULOSIS COMPLEX CULTURE IDENTIFICATION TEST

Model / Serial
Lots (batches): 554628, 555170, 556204 (Foreign Lot): 554840
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.
Manufacturer
Gen-Probe Inc
1 Event
- Recall of Device Recall AccuProbe MYCOBACTERIUM TUBERCULOSIS COMPLEX CULTURE IDENTIFICATION TEST

Manufacturer

Gen-Probe Inc

Manufacturer Address
Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121
Manufacturer Parent Company (2017)
Hologic, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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