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Terminated

Product 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.

FDA Recall Z-1620-2012 · Posted 2012-05-21

Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLLL
Date Initiated2011-06-08
Date Terminated2013-11-15
Product Quantity312 Test Kits

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.

Firm Action

Diamedix 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.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980759DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEMDiamedix Corp. · 1998-04-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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