FDA Device

Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

Hazard

Calibrator C not meeting its optical density specification.

What You Should Do

Remedy

Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.

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Products

Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
Brand
Zeus Scientific Inc
UPC
Product Number: 507-B (Sigma Diagnostics) Lot Number: 090K6499 Expiration Date: 5-31-2002.  Product Number: 2Z921M (Zeus) Lot Number: 00010446 Expiration Date: 06-09-2002

Units Affected

505

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