Diamedix Corporation Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease.
Brand
Diamedix Corporation
Lot Codes / Batch Numbers
Catalog Number # 720-800 -- Lot # S0207, Expiration Date: Nov. 30, 2008.
Products Sold
Catalog Number # 720-800 -- Lot # S0207, Expiration Date: Nov. 30, 2008.
Diamedix Corporation is recalling Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual componen due to Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.
Recommended Action
Per FDA guidance
A Customer Notification Letter was sent to each customer via Certified Mail for domestic customers and via Federal Express for international customer requesting them to contact Diamedix Technical Services to arrange for the return and replacement of any kits of the lot in question. If you have any questions please contact Glenn Gerstenfeld at 1-800-327-4565 or (305) 324-2300.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026