PHADIA Varelisa Cardiolipin IgM Cardiolipin recall
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Why was PHADIA Varelisa Cardiolipin IgM Cardiolipin recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Article Number 15696 Lot number #0067
- Product
- PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
- Recalling firm
- Phadia US Inc
- Quantity
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Distribution
- USA Nationwide.
- Recall date
- September 5, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)