Z-1737-2011

diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or...

Name: Z-1737-2011 diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or...
Creator: DiaDexus, Inc
Published: 2010-08-20
License: https://open.fda.gov/license/

Diadexus, Inc. / initiated 2010-08-20 / Terminated / root cause: manufacturing process

FDA source

DiaDexus, Inc began a recall of diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by... on 2010-08-20. The reason FDA records is "Product fails stability tests prior to expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1737-2011
Status: Terminated
Initiated: 2010-08-20
Posted: 2011-03-21
Terminated: 2011-03-21
Recalling firm: Diadexus, Inc.
Product: diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
Product code: NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Reason for recall: Product fails stability tests prior to expiration date.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.
Quantity in commerce: 482 units
Distribution: Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.
Product codes and lots: Lot number 910013, expiration date 05/31/2010

Product code NOE

K062234Class IIModification to Diadexus Plac TestDiadexus, Inc. / cleared 2006-09-11

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)