Sm ELISA Test System || Product number 2Z2831G and Product number 43270CE || Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. || Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. || Also manufactured for Wampole Laboratories, Princeton, NJ 08540 || Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.
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.
Description du dispositif
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.