Recall Z-1751-2010 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
DiaDexus, Inc
PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90115, Beckman test kit, manufactured by DiaDexus, South San Francisco, CA.
| Date | Jun 3, 2010 (initiated Oct 29, 2009) |
| Status | Terminated |
| Reason | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result. |
| Root cause | Other |
| Action | Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a |
| Quantity | all lots |
| Distribution | Product was distributed to 123 consignees throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 Diadexus, Inc., Dec 20, 2007 |