Device Recall Access Ostase Reagent

Lot Numbers: Expiration dates: 011167 04/30/2011  017561 09/30/2011 014486 7/31/2011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.

Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. || The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.