Recall Z-0990-2010 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Calbiotech Inc
dsDNA IgG ELISA 96 Well Kit, Catalog Number: DD037G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
| Date | Mar 5, 2010 (initiated Aug 27, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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. Th |
| Quantity | 21 kits |
| Distribution | FL, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.