EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all Enzyme Linked Immunosorbent Assay

FDA device recall Z-0994-2010 · posted 2010-03-05 · Terminated

Recall details

Recalling firm

Calbiotech Inc

Reason for recall

The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

Action taken

Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

LSE

Quantity affected

42 Kits

Distribution

FL, and VA

Date initiated

2008-08-27

Date posted

2010-03-05

Date terminated

2010-03-05

Location

Spring Valley, CA