Diamedix Corporation

The kit lot number is 42003. The conjugate lot number is 42023.

Immunology and Microbiology Devices

2

No

Distributed to 54 laboratory accounts throughout the US.

The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. || The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.

Lot # 91803Z and 30804/30804Z

Immunology and Microbiology Devices

2

No

Distributed to Domestic customers only.

The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.

Lot Number 71303, expiration date June 2004

Immunology and Microbiology Devices

2

No

Product was distributed to three hospitals/clinics in AZ, CA and TX.

Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127