PLAC Test Reagent Kit

In-vitro diagnostics

10-0112, 10-0113, 10-0115 | 078011, 088061, 098091, 109011
119021, 129031, 139051, 139051A

IVD: Phospholipase A2 kit

10-0112, 10-0113, 10-0115 | all

IVD: Phospholipase A2 kit

All lot codes under recall.

Immunology and Microbiology Devices

2

No

US, OUS: UK and Germany.

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.

sub lot of lot 088061, expiration date 2008-12

Immunology and Microbiology Devices

2

No

Nationwide Distribution

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 an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.