Recall Z-1737-2011 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
DiaDexus, Inc
diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
| Date | Mar 21, 2011 (initiated Aug 20, 2010) |
| Status | Terminated |
| Reason | Product fails stability tests prior to expiration date. |
| Root cause | Nonconforming Material/Component |
| Action | A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent. |
| Quantity | 482 units |
| Distribution | Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST Diadexus, Inc., Sep 11, 2006 |