DiaDexus, Inc PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Brand
DiaDexus, Inc
Lot Codes / Batch Numbers
All lot codes under recall.
Products Sold
All lot codes under recall.
DiaDexus, Inc is recalling PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitati due to Product may give Lp-PLA2 values at up to 22% lower than accurate values.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product may give Lp-PLA2 values at up to 22% lower than accurate values.
Recommended Action
Per FDA guidance
All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026