FDA Medical Device Recalls (openFDA)
Calbiotech Inc: 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 number
- Z-0992-2010
- Recalling firm
- Calbiotech Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-08-27
- Posted
- 2010-03-05
- Terminated
- 2010-03-05
- 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. 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
- 12 Kits
- Distribution
- FL, and VA
- Lot, serial or model codes
- Lot Number: DEM2514
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NWY
- Firm FEI
- 3002346973
- Firm city
- Spring Valley
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28