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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Diamedix Corporation
- Recall Initiated
- March 21, 2008
- Posted
- September 16, 2008
- Terminated
- February 11, 2009
- Recall Number
- Z-1684-2008
- Quantity
- 174 Test Kits
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Class II Recall - Worldwide Distribution.
Lot / Code Info
Catalog Number # 720-800 -- Lot # S0207, Expiration Date: Nov. 30, 2008.
Root Cause
Environmental control
Action Taken
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.