Z-0445-2013Class II

The Is-anti-Sm test kits**Catalog No: 720-240*

Name: Z-0445-2013 The Is-anti-Sm test kits****Catalog No: 720-240***
Creator: Diamedix Corporation
Published: 2012-08-06
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2012-08-06 / Terminated / root cause: manufacturing process

FDA source

Diamedix Corporation began a recall of The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and... on 2012-08-06. FDA classified it as Class II and gives the reason as "Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0445-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Posted: 2015-06-26
Terminated: 2014-08-08
Recalling firm: Diamedix Corp.
Product: The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Product code: LLL Extractable Antinuclear Antibody, Antigen And Control
Reason for recall: Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Diamedix sent a Customer Notification letter to all affected customers via Certified Mail. The letter identifed the affected product. problem and actions to be taken. The letter instructed customers to contact Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any remaining affected product. For questions call 305-324-2314.
Quantity in commerce: 65 Test Kits
Distribution: Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
Product codes and lots: Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0445-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0445-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-27

Product code LLL

K970220Class IIIs-Anti-Sm Test SystemDiamedix Corp. / cleared 1997-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)