FDA-Device2012-09-05Class III
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Phadia US Inc
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.
Sold states
USA Nationwide.
Affected count
837 kits (96 assays per kit), total of 80,352 individual assays
Manufactured in
4169 Commercial Ave, N/A, Portage, MI, United States
Products
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2285-2012Don't want to check this manually?
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