Recall Z-2400-2008 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
DiaDexus, Inc
PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
| Date | Sep 26, 2008 (initiated Jul 18, 2008) |
| Status | Terminated |
| Reason | Product may give Lp-PLA2 values at up to 22% lower than accurate values. |
| Root cause | Finished device change control |
| Action | 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. |
| Quantity | 65 (total) |
| Distribution | US, OUS: UK and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030477 | DIADEXUS PLAC TEST Diadexus, Inc., Jul 18, 2003 |