Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a
FDA device recall Z-1684-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- 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.
- 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.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- MST
- Quantity affected
- 174 Test Kits
- Distribution
- Class II Recall - Worldwide Distribution.
- Date initiated
- 2008-03-21
- Date posted
- 2008-09-16
- Date terminated
- 2009-02-11
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (K012795) | Diamedix Corp. | 2001-09-28 |