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U.S. Department of Health and Human Services

Class 2 Device Recall PLAC Test Calibrator Kit

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  Class 2 Device Recall PLAC Test Calibrator Kit see related information
Date Initiated by Firm February 09, 2009
Date Posted April 23, 2009
Recall Status1 Terminated 3 on January 05, 2010
Recall Number Z-1205-2009
Recall Event ID 51215
510(K)Number K072599  
Product Classification Lipoprotein-Associated Phosphlipase A2 Immunoassay Test System - Product Code NOE
Product PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA.

Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.
Code Information lot number 048091, expiration date 2009-09.
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		 Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
FDA Determined
Cause 2		 Process control
Action Distributors and Direct accounts were notified by phone followed by Notification letter and certificate of destruction via FedEx. International customers were notified via e-mail with PDF copies of notices, to be followed by hard copies via FedEx. Customers are requested to record the number of kits (full and partial ) they had on the Certificate of Destruction and to dispose of that number of kits with two people signing the form, and then to fax that form to diaDexus.
Quantity in Commerce 105 kits
Distribution Worldwide 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.
510(K) Database 510(K)s with Product Code = NOE and Original Applicant = DIADEXUS, INC.
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