FDA Medical Device Recalls (openFDA)
Zeus Scientific Inc: Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
- Recall number
- Z-1147-03
- Recalling firm
- Zeus Scientific Inc
- Product
- Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
- Status
- Terminated
- Initiated
- 2001-06-22
- Posted
- 2003-08-21
- Terminated
- 2003-08-20
- Reason
- Bacterial contamination of the high positive control.
- Root cause
- Other
- Action
- Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.
- Quantity
- 130
- Distribution
- All product was shipped to St. Louis, MO
- Lot, serial or model codes
- Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001
- 510(k) numbers
- ["K984173"]
- PMA numbers
- not on file
- Product code
- MID
- 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