FDAFDA · Food and drugs·Recall number Z-2285-2012
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Published September 5, 2012 · Recall initiated: August 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Phadia US Inc
- Distributor
- USA Nationwide.
- Lot
- Article Number 15696 Lot number #0067
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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