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U.S. Department of Health and Human Services

Class 2 Device Recall ENA6 Screen Enzyme Immunoassay Test Kit

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 Class 2 Device Recall ENA6 Screen Enzyme Immunoassay Test Kitsee related information
Date Initiated by FirmJune 08, 2011
Date PostedMay 21, 2012
Recall Status1 Terminated 3 on November 15, 2013
Recall NumberZ-1620-2012
Recall Event ID 61568
510(K)NumberK980759 
Product Classification Extractable antinuclear antibody, antigen and control - Product Code LLL
ProductProduct is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***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***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
Code Information Catalog No. 720-230
Recalling Firm/
Manufacturer		 Diamedix Corporation
2140 N. Miami Avenue
Miami FL 33127
For Additional Information Contact
305-324-2560
Manufacturer 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.
FDA Determined
Cause 2		Error in labeling
ActionDiamedix 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.
Quantity in Commerce312 Test Kits
DistributionWorldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLL
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