Z-1205-2009

PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit...

Name: Z-1205-2009 PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit...
Creator: DiaDexus, Inc
Published: 2009-02-09
License: https://open.fda.gov/license/

Diadexus, Inc. / initiated 2009-02-09 / Terminated / root cause: manufacturing process

FDA source

DiaDexus, Inc began a recall of PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog... on 2009-02-09. The reason FDA records is "Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results". 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-1205-2009
Status: Terminated
Initiated: 2009-02-09
Posted: 2009-04-23
Terminated: 2010-01-05
Recalling firm: Diadexus, Inc.
Product: PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.
Product code: NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Reason for recall: Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors and Direct accounts were notified by phone followed by Notification letter and certificate of destruction via FedEx. International customers were notified via e-mail with PDF copies of notices, to be followed by hard copies via FedEx. Customers are requested to record the number of kits (full and partial ) they had on the Certificate of Destruction and to dispose of that number of kits with two people signing the form, and then to fax that form to diaDexus.
Quantity in commerce: 105 kits
Distribution: Worldwide Distribution
Product codes and lots: lot number 048091, expiration date 2009-09.

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)