Phadia Varelisa Cardiolipin IgM Test Kits Recalled for Elevated Results
Phadia US Inc is recalling Varelisa Cardiolipin IgM test kits because a material change combined with a prior instruction to omit a pre-wash step caused elevated assay results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which is defined as unlikely to cause adverse health consequences. The issue is a procedural deviation leading to elevated results, with no reported injuries or illnesses.
Plain-English summary
Phadia US Inc is recalling 837 kits of the PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies). The recall involves Article Number 15696, Lot number #0067, which contains a total of 80,352 individual assays. These products were distributed nationwide in the United States.
The recall was initiated because customers were not following the labeled assay procedure. This deviation occurred due to a letter issued by Phadia GmbH in 2004, which indicated that customers could omit the pre-wash step. The omission of this step, when combined with a change in material source in kit lot #0067, resulted in elevated assay results.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses, injuries, or deaths are reported in the provided text.
The recalled product
- Product
- PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
- Manufacturer
- Phadia US Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Article Number 15696 Lot number #0067
Distribution
Distributed nationwide across the United States.
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