Recall Z-1204-2009 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
DiaDexus, Inc
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical che
| Date | Apr 1, 2009 (initiated Nov 4, 2008) |
| Status | Terminated |
| Reason | Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured. |
| Root cause | Other |
| Action | The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product. |
| Quantity | 27 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.