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U.S. Department of Health and Human Services

Class 2 Device Recall PLAC Test ELISA Kit

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  Class 2 Device Recall PLAC Test ELISA Kit see related information
Date Initiated by Firm March 15, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on January 11, 2011
Recall Number Z-0429-2011
Recall Event ID 56017
Product Classification Test, system, immunoassay, lipoprotein - associated phospolipase a2 - Product Code NOE
Product diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123
The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.
Code Information Lot Number: 907090; Part Number: 90123; Product Code NOE
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		 The reason for the recall is that Real Time Stability Test program showed the kit lot failed stability prior to expiration, affecting samples with results> 500 ng/ml. Results up to 500 ng/ml exhibit passing stability results and are not impacted by this issue.
FDA Determined
Cause 2		 Other
Action DiaDexus notified all customers by phone, including distributor's customers, beginning on March 15, 2010. Customers were told to re-test samples that were tested from 2/1/2010 through 2/28/2010 which have values above 500 ng/ml with a new lot of product. For questions regarding this recall call (650) 246-6477.
Quantity in Commerce 239 kits
Distribution Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
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.
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