Detailed Result for Z-1753-2010

CFRES ID: 86707
Device Name: N/A
Product RES Number: Z-1753-2010
Event Date Initiated: 2009-10-29
Event Date Posted: 2010-06-03
Event Date Created: N/A
Event Date Terminated: 2011-01-26
Recall Status: Terminated
Res Event Number: 53856
Product Code: NOE
K Numbers: ["K072599"]
PMA Numbers: N/A
Product Description: PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
Code Info: Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
Recalling Firm: DiaDexus, Inc
Firm FEI Number: N/A
Adress 1: 343 Oyster Point Blvd
Adress 2: N/A
City: South San Francisco
State: CA
Postal Code: 94080
Additional Contact Info: 650-246-6477
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.
Root Cause Description: Other
Other Submission Description: N/A
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.
Product Quantity: all lots
Distribution Pattern: Product was distributed to 123 consignees throughout the US.
Medical Speciality Description: N/A
Regulation Number: N/A
Event Date Posted: 2010-06-03
Device Class: N/A
Open FDA: {"k_number"=>["K050523", "K141575", "K203136", "K101853", "K030477", "K062234", "K072599", "K040101"], "registration_number"=>["2032900", "1721937"], "fei_number"=>["1000117401", "3004445302"], "device_name"=>"Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2", "medical_specialty_description"=>"Immunology", "regulation_number"=>"866.5600", "device_class"=>"2"}
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