FDA Medical Device Recalls (openFDA)
Zeus Scientific Inc: Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
- Recall number
- Z-1065-03
- Recalling firm
- Zeus Scientific Inc
- Product
- Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
- Status
- Terminated
- Initiated
- 2000-02-24
- Posted
- 2003-07-30
- Terminated
- 2004-10-25
- Reason
- The high positive control/low positive standard ratio recovering too low.
- Root cause
- Other
- Action
- Recall letters sent out via DHL on 2/24/2000
- Quantity
- 205
- Distribution
- The two lots were shipped to St. Louis, MO. No subrecall was initiated.
- Lot, serial or model codes
- Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491 Exp. 10-02-2001; 090K6483 Exp. 5-31-2002.
- 510(k) numbers
- ["K984180"]
- PMA numbers
- not on file
- Product code
- LFX
- 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