Z-0991-2010

Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are all Enzyme Linked...

Name: Z-0991-2010 Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are all Enzyme Linked...
Creator: Calbiotech Inc
Published: 2008-08-27
License: https://open.fda.gov/license/

Calbiotech Inc / initiated 2008-08-27 / Terminated / root cause: labeling and UDI

FDA source

Calbiotech Inc began a recall of 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... on 2008-08-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0991-2010
Status: Terminated
Initiated: 2008-08-27
Posted: 2010-03-05
Terminated: 2010-03-05
Recalling firm: Calbiotech Inc
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.
Product code: NWY Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
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.
Root cause tag: labeling and UDI
FDA 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. 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
Product codes and lots: Lot Number: DEG2398, and DEG2488

Product code NWY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)