|
Class 2 Device Recall PLAC Test Reagent Kit, immunoturbidimetric method |
|
Date Initiated by Firm |
October 29, 2009 |
Date Posted |
June 03, 2010 |
Recall Status1 |
Terminated 3 on January 26, 2011 |
Recall Number |
Z-1750-2010 |
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 90112, 50 test kit, 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.
|
|
|
|