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U.S. Department of Health and Human Services

Class 2 Device Recall diaDexus PLAC Test Reagent Kit

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  Class 2 Device Recall diaDexus PLAC Test Reagent Kit see related information
Date Initiated by Firm November 04, 2008
Date Posted April 01, 2009
Recall Status1 Terminated 3 on December 21, 2009
Recall Number Z-1204-2009
Recall Event ID 50482
Product Classification Lipoprotein-associated phospholipase a2 Immunoassay Test System - Product Code NOE
Product diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110

Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
Code Information sub lot of lot 088061, expiration date 2008-12
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		 Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.
FDA Determined
Cause 2		 Other
Action The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product.
Quantity in Commerce 27 units
Distribution Nationwide Distribution
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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