Z-2285-2012 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- August 2, 2012
- Termination Date
- December 12, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 837 kits (96 assays per kit), total of 80,352 individual assays
Product Description
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Reason for Recall
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.
Distribution Pattern
USA Nationwide.
Code Information
Article Number 15696 Lot number #0067