igm elisa

Model: Catalogue Number: E-BFV01M / E-BFV01M05, Affected: Lots: 12354, 13051, 13140

Model: E-BFV01M/E-BFV01M05, Affected:

ivd

Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491 Exp. 10-02-2001; 090K6483 Exp. 5-31-2002.

Immunology and Microbiology Devices

2

No

The two lots were shipped to St. Louis, MO. No subrecall was initiated.

Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

Lot 04027128 exp 2005-10

Immunology and Microbiology Devices

2

No

25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities.

Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.