Device product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Z-2285-2012
Product summary
- Firm
- Phadia US Inc
- Event
- Event 62572
- Status
- Terminated
- Classification
- Class III
- Quantity
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Official record key
device-enforcement:Z-2285-2012
Official wording
Reason: 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.
Code information: Article Number 15696 Lot number #0067
Distribution pattern: USA Nationwide.
Derived failure modes
-
Unknown
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.