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U.S. Department of Health and Human Services

Class 3 Device Recall HSV 1&2 IgM Enzyme Immunoassay Test Kit

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  Class 3 Device Recall HSV 1&2 IgM Enzyme Immunoassay Test Kit see related information
Date Initiated by Firm January 16, 2012
Date Posted May 10, 2012
Recall Status1 Terminated 3 on May 18, 2012
Recall Number Z-1520-2012
Recall Event ID 61577
510(K)Number K002262  
Product Classification Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
Product 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.
Code Information Lot # 60701
Recalling Firm/
Manufacturer		 Diamedix Corporation
2140 N. Miami Avenue
Miami FL 33127
For Additional Information Contact Glenn Gerstenfeld
305-324-2560
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 442 kits
Distribution Nationwide Distribution and Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LGC and Original Applicant = DIAMEDIX CORP.
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