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.
FDA Recall Z-0214-05 · Posted 2004-11-20
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Recalling FirmZeus Scientific Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2004-08-30
Date Terminated2006-10-03
Product Quantity25 kits
Reason for Recall
During packaging, Lyme plates were packaged in this kit in error.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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