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U.S. Department of Health and Human Services

Class 2 Device Recall EBV VCA IgM ELISA 96 Well Kit

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 Class 2 Device Recall EBV VCA IgM ELISA 96 Well Kitsee related information
Date Initiated by FirmAugust 27, 2008
Date PostedMarch 05, 2010
Recall Status1 Terminated 3 on March 05, 2010
Recall NumberZ-0994-2010
Recall Event ID 50691
Product Classification Epstein-Barr Virus, Other - Product Code LSE
ProductEBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Code Information Lot Number: EVM2409, EVM2480, EVM2508, EVM2612, and EVM2638
Recalling Firm/
Manufacturer		 Calbiotech Inc
10461 Austin Dr Ste G
Spring Valley CA 91978-1524
For Additional Information Contact
619-660-6162
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionImmediately 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.
Quantity in Commerce42 Kits
DistributionFL, and VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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