Extractable Antinuclear Antibody, Antigen And Control

Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Suffi

On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.

RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.

In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.

Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.

An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.

The Is-anti-Sm test kits****Catalog No: 720-240***

Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.