(List Number On the Box---List Number On the bottle---Lot Number): 99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2; 08H17-01---08H17-02---16823I2; 08H17-01---08H17-02---17906I2; 08H17-01---08H17-02---17907I2; 08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2; 08H17-01---08H17-02---19296I2; 08H17-01---08H17-02---20413I2; 08H17-01---08H17-02---21540I2; 08H17-01---08H17-02---22739I2; 08H17-01---08H17-02---23889I2 Expanded: All lots under recall.
Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to assess their inventory of DILUENT 08H17-01 and 99226-01 to determine if they had any of the affected lots in their possession. Foreign countries include: Canada, Columbia, Uruguay, Germany, Barbados, Bermuda, Cayman Islands.
Description du dispositif
Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, || List Numbers: || 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); || Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054
It is a fully automated immunoassay system that allows random and continuous access, as well as priority processing and automatic re-analysis using chemoluminescent micro-particle immunoassay technology. CMIA technology is used to determine the presence of antigens, antibodies and analytes in samples. The scalable design of the ALINITY I allows one or more sample processing modules, in multiple configurations, with a system control module to physically join together to form a single workstation.