PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.
FDA Recall Z-1748-2010 · Posted 2010-06-03
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Recalling FirmDiaDexus, Inc
Recall StatusTerminated
Product CodeNOE
Date Initiated2009-10-29
Date Terminated2011-01-26
Product Quantityall lots
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to 123 consignees throughout the US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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