PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Reported: September 5, 2012 Initiated: August 2, 2012 #Z-2285-2012
Product Description
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Reason for Recall
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.
Details
- Recalling Firm
- Phadia US Inc
- Units Affected
- 837 kits (96 assays per kit), total of 80,352 individual assays
- Distribution
- USA Nationwide.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies). Recalled by Phadia US Inc. Units affected: 837 kits (96 assays per kit), total of 80,352 individual assays.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2012. Severity: Low. Recall number: Z-2285-2012.
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