U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
제품 설명
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.