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 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.
FDA Recall Z-1520-2012 · Posted 2012-05-10
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Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLGC
Date Initiated2012-01-16
Date Terminated2012-05-18
Product Quantity442 kits
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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