Devices

Device Recall BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte

Model / Serial
Lot Numbers: 943712 Exp. 7/30/07 and 943713 Exp. 4/30/08
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Product Description
BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.
Manufacturer
Bio-Rad Laboratories
1 Event
- Recall of Device Recall BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte

Manufacturer

Bio-Rad Laboratories

Manufacturer Address
Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
Manufacturer Parent Company (2017)
Bio-Rad Laboratories 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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