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Phadia US Inc recalls PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Recalled September 5, 2012 · FDA recall Z-2285-2012 · Phadia US
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. · FDA Class III
Units
837 kits (96 assays per kit), total of 80,352 individual assays
Sold at
USA Nationwide.
Description
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.
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Manufacturer(s)
Phadia US Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →