FDA Medical Device Recalls (openFDA)
Zeus Scientific Inc: Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
- Recall number
- Z-0961-03
- Recalling firm
- Zeus Scientific Inc
- Product
- Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
- Status
- Terminated
- Initiated
- 2001-03-19
- Posted
- 2003-07-02
- Terminated
- 2006-10-03
- Reason
- Mix-up between low positive and negative controls.
- Root cause
- Other
- Action
- Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus.
- Quantity
- 15 kits
- Distribution
- NJ
- Lot, serial or model codes
- Lot No: 00008066; Expiration Date: 08-11-2001.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJB
- Firm FEI
- 2242436
- Firm city
- Branchburg
- Firm state
- NJ
- 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