Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230**
FDA device recall Z-1620-2012 · posted 2012-05-21 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- Reason for recall
- On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.
- Action taken
- Diamedix Corporation sent a Customer notification letter dated June 8, 2011, to all affected customers via Certified Mail. Customers were instructed to search their inventory and to return affected product to Diamedix. Diamedix apologizes for any inconvenience this has caused our valued customers. Please contact the Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any kits you might still have of the lot in question. Please rest assured that Diamedix values you as a customer and is in the process of taking the proper corrective and preventive actions.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LLL
- Quantity affected
- 312 Test Kits
- Distribution
- Worldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.
- Date initiated
- 2011-06-08
- Date posted
- 2012-05-21
- Date terminated
- 2013-11-15
- 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-ENA-6 SCREEN TEST SYSTEM (K980759) | Diamedix Corp. | 1998-04-23 |