DiaDexus, Inc diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as
Brand
DiaDexus, Inc
Lot Codes / Batch Numbers
sub lot of lot 088061, expiration date 2008-12
Products Sold
sub lot of lot 088061, expiration date 2008-12
DiaDexus, Inc is recalling diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of due to Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The inte. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.
Recommended Action
Per FDA guidance
The firm and its distributor contacted the consignees via phone on 11/04/08. The firm informed them of the issue and inquired about the products' status. An Urgent: Device Recall letter was issued on 11/04/08 via FedEx. The letter requested that use of the kit be immediately discontinued and returned promptly. A phone call was made to follow up requesting return of the product.
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