Recall Z-1684-2008 ยท MST Antibodies, Gliadin
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.
| Date | Sep 16, 2008 (initiated Mar 21, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 174 Test Kits |
| Distribution | Class II Recall - Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM Diamedix Corp., Sep 28, 2001 |