FDA Medical Device Recalls (openFDA)
Zeus Scientific Inc: Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
- Recall number
- Z-1031-03
- Recalling firm
- Zeus Scientific Inc
- Product
- Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
- Status
- Terminated
- Initiated
- 2001-11-09
- Posted
- 2003-07-19
- Terminated
- 2006-10-03
- Reason
- Calibrator C not meeting its optical density specification.
- Root cause
- Other
- Action
- Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.
- Quantity
- 505
- Distribution
- The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.
- Lot, serial or model codes
- Product Number: 507-B (Sigma Diagnostics) Lot Number: 090K6499 Expiration Date: 5-31-2002. Product Number: 2Z921M (Zeus) Lot Number: 00010446 Expiration Date: 06-09-2002
- 510(k) numbers
- ["K961277"]
- PMA numbers
- not on file
- Product code
- DHR
- 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