Class 3 Device Recall PHADIA VarelisA Cardiolipin IgM Antibodies Assay

• Date Initiated by Firm: August 02, 2012
• Date Posted: August 28, 2012
• Recall Status: Terminated on December 12, 2012
• Recall Number: Z-2285-2012
• Recall Event ID: 62572
• 510(K)Number: K020758
• Product Classification: in vitro diagnostic - Product Code MID
• Product: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
• Code Information: Article Number 15696 Lot number #0067
• FEI Number: 3004973408
• Recalling Firm/ Manufacturer: Phadia US Inc; 4169 Commercial Ave; Portage MI 49002-9701
• For Additional Information Contact: 269-833-1819
• Manufacturer 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.
• FDA Determined Cause: Labeling Change Control
• Action: On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004.
• Quantity in Commerce: 837 kits (96 assays per kit), total of 80,352 individual assays
• Distribution: USA Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MID