FDAClass IIDecember 5, 2012

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

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…

Why was The Is-anti-Sm test kits****Catalog No: 720-240*** recalled?

Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012

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…
Recalling firm
Diamedix Corporation
Quantity
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
Recall date
December 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls