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U.S. Department of Health and Human Services

Class 2 Device Recall PLAC Test Reagent Kit, immunoturbidimetric method

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  Class 2 Device Recall PLAC Test Reagent Kit, immunoturbidimetric method see related information
Date Initiated by Firm October 29, 2009
Date Posted June 03, 2010
Recall Status1 Terminated 3 on January 26, 2011
Recall Number Z-1749-2010
Recall Event ID 53856
510(K)Number K072599  
Product Classification Test, system, immunoassay, lipoprotein-associated phospholipase a2 - Product Code NOE
Product PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90110, 100 test kit (obsolete), manufactured by DiaDexus, South San Francisco, CA.
Code Information Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
Recalling Firm/
Manufacturer		 DiaDexus, Inc
343 Oyster Point Blvd
South San Francisco CA 94080
For Additional Information Contact
650-246-6477
Manufacturer Reason
for Recall		 Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
FDA Determined
Cause 2		 Other
Action Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.
Quantity in Commerce all lots
Distribution Product was distributed to 123 consignees throughout the US.
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 = NOE and Original Applicant = DIADEXUS, INC.
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