Cardiolipin IgM ELISA 96 Well Kit, Catalog Number: CA036M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall Z-0984-2010 · Posted 2010-03-05
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Recalling FirmCalbiotech Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2008-08-27
Date Terminated2010-03-05
Product Quantity2
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
FL, and VA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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