Devices

Device Recall BSure

Model / Serial
All lots.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
United States .
Product Description
B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
Manufacturer
Harmony Brands Llc
1 Event
- Recall of Device Recall BSure

Manufacturer

Harmony Brands Llc

Manufacturer Address
Harmony Brands Llc, 13240 Capital St, Oak Park MI 48237-3159
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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