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.
FDA Recall Z-1205-2009 · Posted 2009-04-23
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Recalling FirmDiaDexus, Inc
Recall StatusTerminated
Product CodeNOE
Date Initiated2009-02-09
Date Terminated2010-01-05
Product Quantity105 kits
Reason for Recall
Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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