diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.
FDA Recall Z-1737-2011 · Posted 2011-03-21
Recalling FirmDiaDexus, Inc
Recall StatusTerminated
Product CodeNOE
Date Initiated2010-08-20
Date Terminated2011-03-21
Product Quantity482 units
Reason for Recall
Product fails stability tests prior to expiration date.
Firm Action
A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.
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.