bioMérieux Receives FDA Clearance to Test Leukocyte-Reduced
Single Unit Whole Blood Platelet Concentrates (WBPC)

March 8, 2004 – bioMérieux^® INDUSTRY announces The United States Food and Drug Administration Center for Biologics Evaluation and Research (FDA-CBER) Premarket Notification 510(k) clearance of plastic BacT/ALERT^® BPA and BacT/ALERT BPN culture bottles with an additional claim of microbial quality control testing of leukocyte-reduced single units of whole blood platelet concentrates (WBPC).

Implemented March 1, 2004 , the American Association of Blood Banks (AABB) Standard (5.1.5.1) for Bacterial Contamination now requires Blood Banks and Transfusion Services to limit and detect bacterial contamination in all platelet components. BacT/ALERT now has the capability to perform microbial quality control testing of leukocyte reduced apheresis platelet (LRAP) units and leukocyte-reduced single units of whole blood platelet concentrates (WBPC).

Built on bioMérieux's patented colorimetric technology, the BacT/ALERT 3D demonstrates excellent recovery of a wide range of organisms typically found in leukocyte reduced platelets. BacT/ALERT Culture Media offer the ability to detect anaerobic and aerobic microorganisms. Constant sample monitoring alerts the user immediately to positive samples. BacT/ALERT 3D's patented colorimetric sensor-and-detection technology detects microorganism growth by tracking CO₂ production. Notification of positives is immediate and results are dependable.

About bioMérieux INDUSTRY

bioMérieux INDUSTRY provides product solutions to quality control and research microbiology laboratories. Applications served include environmental monitoring, sterility testing, pathogen screening, quality indicators, microbial identification, quality control organisms, microbial limits and preservative effectiveness testing.

About bioMerieux

A global leader in disease prevention and management, bioMérieux provides assays, reagents and instrumentation for clinical microbiology, coagulation, immunoassay, and nucleic acid diagnostics; and also for product quality control in the blood bank, agri-food, cosmetics and pharmaceutical industries. Based in Marcy-l'Etoile, France, the company's U.S. headquarters is in Durham, North Carolina .

With sales of 1 billion Euros in 2002, bioMérieux ranks as the eighth-largest biological diagnostics company worldwide. Over 81% of its activity takes place on an international level. Investment in research and development represents 13% of sales.

bioMérieux employs 5400 people throughout the world, including 3200 in Europe and 1500 in the U.S. The group has 15 production sites located in France, the United States, Brazil, Italy and the Netherlands, as well as a European logistics center in France .

Already present in over 130 countries, with more than 110 distributors and 32 subsidiaries, bioMérieux continues its international development by strengthening its presence in Latin America and Asia .

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