FDAClass IIIAugust 8, 2018

Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit recall

Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

Why was Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit recalled?

Contains a gel-like contaminant that may affect product performance.

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?

Lot T0006 Exp. 05/31/2018

Product
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Recalling firm
Diamedix Corporation
Quantity
147
Distribution
AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
Recall date
August 8, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls