FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1737-2011
- Recalling firm
- DiaDexus, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-08-20
- Posted
- 2011-03-21
- Terminated
- 2011-03-21
- 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.
- Lot, serial or model codes
- Lot number 910013, expiration date 05/31/2010
- 510(k) numbers
- ["K062234"]
- PMA numbers
- not on file
- Product code
- NOE
- Firm FEI
- 3003643666
- Firm city
- South San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28