Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM Recalled by Phadia US Inc Due to Customers were not following the labeled assay procedure....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Phadia US Inc directly.
Affected Products
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Quantity: 837 kits (96 assays per kit), total of 80,352 individual assays
Why Was This Recalled?
Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Phadia US Inc
Phadia US Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report