Dengue IgM ELISA 96 Well Kit, Catalog Number: DE051M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Recall
- Recall Number
- Z-0992-2010
- Event Number
- 50691
- Firm
- Calbiotech Inc
- FEI Number
- 3002346973
- Product Code
- NWY
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- August 27, 2008
- Posted
- March 5, 2010
- Terminated
- March 5, 2010
- Address
- 10461 Austin Dr, Ste G, Spring Valley, CA, 91978-1524
Description
Dengue IgM ELISA 96 Well Kit, Catalog Number: DE051M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
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.
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.
FL, and VA
12 Kits