Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of H
FDA device recall Z-1520-2012 · posted 2012-05-10 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- Reason for recall
- On 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp. June 30, 2012. The Positive Control for this lot is Out of Specification.
- Action taken
- Diamedix sent Recall notification letters dated January 16, 2012, to all affected customers by Certified Mail. Consignees were asked to review their inventory and then contact Diamedix to request replacement product. Customers were instructed to call 305-324-2314 with questions. For questions regarding this recall call 305-324-2560.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LGC
- Quantity affected
- 442 kits
- Distribution
- Nationwide Distribution and Puerto Rico.
- Date initiated
- 2012-01-16
- Date posted
- 2012-05-10
- Date terminated
- 2012-05-18
- 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-HSV 1&2 IGM TEST SYSTEM (K002262) | Diamedix Corp. | 2000-11-28 |