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U.S. Department of Health and Human Services

Class 2 Device Recall Dengue IgG ELISA 96 Well Kit

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  Class 2 Device Recall Dengue IgG ELISA 96 Well Kit see related information
Date Initiated by Firm August 27, 2008
Date Posted March 05, 2010
Recall Status1 Terminated 3 on March 05, 2010
Recall Number Z-0991-2010
Recall Event ID 50691
Product Classification Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies - Product Code NWY
Product Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G


The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Code Information Lot Number: DEG2398, and DEG2488
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
Action 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.
Quantity in Commerce 16 kits
Distribution FL, and VA
Total Product Life Cycle TPLC 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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