FDA Medical Device Recalls (openFDA)
Zeus Scientific Inc: Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.
- Recall number
- Z-0214-05
- Recalling firm
- Zeus Scientific Inc
- Product
- Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.
- Status
- Terminated
- Initiated
- 2004-08-30
- Posted
- 2004-11-20
- Terminated
- 2006-10-03
- Reason
- During packaging, Lyme plates were packaged in this kit in error.
- Root cause
- Other
- Action
- Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.
- Quantity
- 25 kits
- Distribution
- 25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities.
- Lot, serial or model codes
- Lot 04027128 exp 2005-10
- 510(k) numbers
- ["K981021"]
- PMA numbers
- not on file
- Product code
- MID
- Firm FEI
- 2242436
- Firm city
- Somerville
- 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