diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, par
FDA device recall Z-1737-2011 · posted 2011-03-21 · Terminated
Recall details
- Recalling firm
- DiaDexus, Inc
- Reason for recall
- Product fails stability tests prior to expiration date.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NOE
- Quantity affected
- 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.
- Date initiated
- 2010-08-20
- Date posted
- 2011-03-21
- Date terminated
- 2011-03-21
- 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 |
|---|---|---|
| MODIFICATION TO DIADEXUS PLAC TEST (K062234) | Diadexus, Inc. | 2006-09-11 |