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Terminated

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.

FDA Recall Z-0429-2011 · Posted 2010-11-22

Recalling FirmDiaDexus, Inc
Recall StatusTerminated
Product CodeNOE
Date Initiated2010-03-15
Date Terminated2011-01-11
Product Quantity239 kits

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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