Z-1753-2010

PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit...

Name: Z-1753-2010 PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit...
Creator: DiaDexus, Inc
Published: 2009-10-29
License: https://open.fda.gov/license/

Diadexus, Inc. / initiated 2009-10-29 / Terminated

FDA source

DiaDexus, Inc began a recall of PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA on 2009-10-29. The reason FDA records is "Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1753-2010
Status: Terminated
Initiated: 2009-10-29
Posted: 2010-06-03
Terminated: 2011-01-26
Recalling firm: Diadexus, Inc.
Product: PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
Product code: NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Reason for recall: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
FDA root cause: Other
Action: Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.
Quantity in commerce: all lots
Distribution: Product was distributed to 123 consignees throughout the US.
Product codes and lots: Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A

Product code NOE

K072599Class IIPlac Test Reagent Kit,calibrator Kit, Lp-Pla2 Control Kit, Model(s) 90107,90109,90109Diadexus, Inc. / cleared 2007-12-20

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)