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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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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
Distribution Pattern USA Nationwide.

Product Detail

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