Z-2399-2008

PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative...

Name: Z-2399-2008 PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative...
Creator: DiaDexus, Inc
Published: 2008-07-18
License: https://open.fda.gov/license/

Diadexus, Inc. / initiated 2008-07-18 / Terminated

FDA source

DiaDexus, Inc began a recall of PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum... on 2008-07-18. The reason FDA records is "Product may give Lp-PLA2 values at up to 22% lower than accurate values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2399-2008
Status: Terminated
Initiated: 2008-07-18
Posted: 2008-09-26
Terminated: 2009-12-22
Recalling firm: Diadexus, Inc.
Product: PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Product code: NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Reason for recall: Product may give Lp-PLA2 values at up to 22% lower than accurate values.
FDA root cause: Finished device change control
Action: All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.
Quantity in commerce: 65 (total)
Distribution: US, OUS: UK and Germany.
Product codes and lots: All lot codes under recall.

Product code NOE

K030477Class IIDiadexus Plac TestDiadexus, Inc. / cleared 2003-07-18

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)