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U.S. Department of Health and Human Services

Class 3 Device Recall PHADIA VarelisA Cardiolipin IgM Antibodies Assay

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  Class 3 Device Recall PHADIA VarelisA Cardiolipin IgM Antibodies Assay see related information
Date Initiated by Firm August 02, 2012
Date Posted August 28, 2012
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = PHARMACIA DEUTSCHLAND GMBH
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