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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description PHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Recall Number Z-2285-2012
Classification Class III
Code Info Article Number 15696 Lot number #0067
Product Distributed Qty 837 kits (96 assays per kit), total of 80,352 individual assays
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.

Event Detail

Event Id 62572
Product Type Devices
Status Ongoing
Recalling Firm Phadia US Inc
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide.