PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in
FDA device recall Z-1205-2009 · posted 2009-04-23 · Terminated
Recall details
- Recalling firm
- DiaDexus, Inc
- Reason for recall
- Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.
- Action taken
- 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
- Status
- Terminated
- Product code
- NOE
- Quantity affected
- 105 kits
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-02-09
- Date posted
- 2009-04-23
- Date terminated
- 2010-01-05
- Location
- South San Francisco, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 (K072599) | Diadexus, Inc. | 2007-12-20 |