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CFRES ID:
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86707 |
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Device Name:
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N/A |
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Product RES Number:
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Z-1753-2010 |
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Event Date Initiated:
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2009-10-29 |
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Event Date Posted:
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2010-06-03 |
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Event Date Created:
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N/A |
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Event Date Terminated:
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2011-01-26 |
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Recall Status:
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Terminated |
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Res Event Number:
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53856 |
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Product Code:
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NOE |
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K Numbers:
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["K072599"] |
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PMA Numbers:
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N/A |
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Product Description:
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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. |
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Code Info:
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Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A |
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Recalling Firm:
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DiaDexus, Inc |
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Firm FEI Number:
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N/A |
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Adress 1:
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343 Oyster Point Blvd |
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Adress 2:
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N/A |
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City:
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South San Francisco |
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State:
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CA |
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Postal Code:
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94080 |
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Additional Contact Info:
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650-246-6477 |
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Reason for Recall:
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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. |
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Root Cause Description:
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Other |
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Other Submission Description:
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N/A |
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Action:
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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. |
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Product Quantity:
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all lots |
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Distribution Pattern:
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Product was distributed to 123 consignees throughout the US. |
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Medical Speciality Description:
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N/A |
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Regulation Number:
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N/A |
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Event Date Posted:
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2010-06-03 |
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Device Class:
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N/A |
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Open FDA:
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{"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"} |