Z-1684-2008

Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components...

Name: Z-1684-2008 Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components...
Creator: Diamedix Corporation
Published: 2008-03-21
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2008-03-21 / Terminated / root cause: manufacturing process

FDA source

Diamedix Corporation began a recall of Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800... on 2008-03-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1684-2008
Status: Terminated
Initiated: 2008-03-21
Posted: 2008-09-16
Terminated: 2009-02-11
Recalling firm: Diamedix Corp.
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.
Product code: MST Antibodies, Gliadin
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: 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.
Quantity in commerce: 174 Test Kits
Distribution: Class II Recall - Worldwide Distribution.
Product codes and lots: Catalog Number # 720-800 -- Lot # S0207, Expiration Date: Nov. 30, 2008.

Product code MST

K012795Class IIDiamedix Is-Anti-Gliadin Igg Test SystemDiamedix Corp. / cleared 2001-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)