Z-0214-05

Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and...

Name: Z-0214-05 Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and...
Creator: Zeus Scientific Inc
Published: 2004-08-30
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2004-08-30 / Terminated / root cause: packaging

FDA source

Zeus Scientific Inc began a recall of Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and... on 2004-08-30. The reason FDA records is "During packaging, Lyme plates were packaged in this kit in error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0214-05
Status: Terminated
Initiated: 2004-08-30
Posted: 2004-11-20
Terminated: 2006-10-03
Recalling firm: Zeus Scientific LLC
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.
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: During packaging, Lyme plates were packaged in this kit in error.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Lot 04027128 exp 2005-10

Product code MID

K981021Class IIZeus Anti-Cardiolipin Igm Test SystemZeus Scientific, Inc. / cleared 1998-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)