DiaDexus, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
DiaDexus, Inc
Lot Codes / Batch Numbers
lot number 048091, expiration date 2009-09.
Products Sold
lot number 048091, expiration date 2009-09.
DiaDexus, Inc is recalling PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reage due to Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026