Device Recall BioPlex 2200

Lot Numbers: 946314 Exp. 10/31/07, 950630 Exp. 1/31/08 and 946899 Exp. 2/28/08.

Immunology and Microbiology Devices

2

No

Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum.

Lot Numbers: 943710 Exp. 7/30/07 and 943711 Exp. 4/30/08

Immunology and Microbiology Devices

1

No

Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).

Lot Numbers: 943712 Exp. 7/30/07 and 943713 Exp. 4/30/08

Immunology and Microbiology Devices

1

No

Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

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.

Eleven (11) Lots, as follows: Lot Numbers: 931396 Exp. 9/30/06; 935424 Exp. 3/31/07; 941886 Exp. 3/31/07; 935682 Exp. 4/30/07; 937351 Exp. 6/30/07; 941343 Exp. 3/31/08; 941428 Exp. 4/30/08; 945246 Exp. 9/30/08; 945875 Exp. 12/31/08; 945248 Exp. 10/31/08 and 945875 Exp. 12/31/08 ****

Immunology and Microbiology Devices

2

No

Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.

Catalog #: 663-1430 Lot #: 46636

Immunology and Microbiology Devices

2

No

Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.

BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 || The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.