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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zeus Scientific Inc
Lot Codes / Batch Numbers
Lot 04027128 exp 2005-10
Products Sold
Lot 04027128 exp 2005-10
Zeus Scientific Inc is recalling Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, due to During packaging, Lyme plates were packaged in this kit in error.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During packaging, Lyme plates were packaged in this kit in error.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026