PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of
FDA device recall Z-2399-2008 · posted 2008-09-26 · Terminated
Recall details
- Recalling firm
- DiaDexus, Inc
- Reason for recall
- Product may give Lp-PLA2 values at up to 22% lower than accurate values.
- Action taken
- All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- NOE
- Quantity affected
- 65 (total)
- Distribution
- US, OUS: UK and Germany.
- Date initiated
- 2008-07-18
- Date posted
- 2008-09-26
- Date terminated
- 2009-12-22
- 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 |
|---|---|---|
| DIADEXUS PLAC TEST (K030477) | Diadexus, Inc. | 2003-07-18 |