—#107581

Product

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.

FDA product code: CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K994278
Affected lot / code info: Lot Numbers: Expiration dates: 011167 04/30/2011 017561 09/30/2011 014486 7/31/2011

Why it was recalled

The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.

Root cause (FDA determination)

Process design

Action the firm took

Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-11-10
Posted by FDA: 2012-03-21
Terminated: 2012-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107581. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.