FDA Medical Device Recalls (openFDA)
DiaDexus, Inc: PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.
- Recall number
- Z-1748-2010
- Recalling firm
- DiaDexus, Inc
- Product
- PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.
- Status
- Terminated
- Initiated
- 2009-10-29
- Posted
- 2010-06-03
- Terminated
- 2011-01-26
- 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 sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.
- Quantity
- all lots
- Distribution
- Product was distributed to 123 consignees throughout the US.
- Lot, serial or model codes
- Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
- 510(k) numbers
- ["K072599"]
- 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