FDA Device

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

Hazard

Bacterial contamination of the high positive control.

What You Should Do

Remedy

Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.

Products

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
Brand
Zeus Scientific Inc
UPC
Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001

Units Affected

130