FDA Medical Device Recalls (openFDA)
Immuno Concepts Inc: RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
- Recall number
- Z-1045-2009
- Recalling firm
- Immuno Concepts Inc
- Product
- RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
- Status
- Terminated
- Initiated
- 2008-11-25
- Posted
- 2009-04-06
- Terminated
- 2009-11-17
- Reason
- In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
- Root cause
- Process control
- Action
- The firm has issued telephone calls, e-mails and notification letters to its consignees.
- Quantity
- 25 kits
- Distribution
- Worldwide Distribution including USA, Australia, England, Sweden and Austria.
- Lot, serial or model codes
- Kit Catalog Number 7096-09, Lot Number 0821407 and Kit Catalog Number 7696-09, Lot Number 0821404.
- 510(k) numbers
- ["K935129"]
- PMA numbers
- not on file
- Product code
- LLL
- Firm FEI
- 2918768
- Firm city
- Sacramento
- 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