Recall Z-1520-2012 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Diamedix Corporation
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33
| Date | May 10, 2012 (initiated Jan 16, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 442 kits |
| Distribution | Nationwide Distribution and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM Diamedix Corp., Nov 28, 2000 |