FDA Medical Device Recalls (openFDA)
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 number
- Z-1205-2009
- 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.
- Status
- Terminated
- Initiated
- 2009-02-09
- Posted
- 2009-04-23
- Terminated
- 2010-01-05
- Reason
- Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
- 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
- 105 kits
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- lot number 048091, expiration date 2009-09.
- 510(k) numbers
- ["K072599"]
- PMA numbers
- not on file
- Product code
- NOE
- Firm FEI
- 3003643666
- Firm city
- South San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28