PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90112, 50 test kit, manufactured by DiaDexus, South San

FDA device recall Z-1750-2010 · posted 2010-06-03 · Terminated

Recall details

Recalling firm

DiaDexus, Inc

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

NOE

Quantity affected

all lots

Distribution

Product was distributed to 123 consignees throughout the US.

Date initiated

2009-10-29

Date posted

2010-06-03

Date terminated

2011-01-26

Location

South San Francisco, CA

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