Z-0429-2011

diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model...

Name: Z-0429-2011 diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model...
Creator: DiaDexus, Inc
Published: 2010-03-15
License: https://open.fda.gov/license/

Diadexus, Inc. / initiated 2010-03-15 / Terminated

FDA source

DiaDexus, Inc began a recall of diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 The diaDexusPLAC Test ELISA... on 2010-03-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0429-2011
Status: Terminated
Initiated: 2010-03-15
Posted: 2010-11-22
Terminated: 2011-01-11
Recalling firm: Diadexus, Inc.
Product: 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.
Product code: NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
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.
FDA root cause: Other
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.
Quantity in commerce: 239 kits
Distribution: Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.
Product codes and lots: Lot Number: 907090; Part Number: 90123; Product Code NOE

Product code NOE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)