Devices

Device Recall Premier Platinum HpSA

Model / Serial
Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070, Exp Date 22 SEP 03; Kit Catalog #601348
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
Product Description
Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
Manufacturer
Meridian Bioscience Inc
1 Event
- Recall of Device Recall Premier Platinum HpSA

Manufacturer

Meridian Bioscience Inc

Manufacturer Address
Meridian Bioscience Inc, 3471 River Hills Dr, Cincinnati OH 45244
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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