“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
All pre production units with Serial numbers S-001 to S-026 and all production units with serial numbers 42003AZ-42007AZ, 42010AZ-42030AZ, 42032AZ-42033AZ, 42037AZ-42059AZ, 42061AZ-42062AZ, 42064AZ-42067AZ, 42072AZ-42074AZ, 42076AZ-42081AZ, 42083AZ-42123AZ, 42125AZ-42852AZ, 42854AZ-42944AZ, 42946AZ-42949AZ, 42951AZ, 42953AZ, 42955AZ-42961AZ, and 42963AZ-42964AZ
Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.
Description du dispositif
CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 || A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 || The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.
Worldwide Distribution -- US, Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela.
Description du dispositif
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA. || Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes
Worldwide Distribution -- USA, including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Dominica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand Trinidad and Tobago, Turks & Caicos, Uruguay, and Venezuela.
Description du dispositif
Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader), Manufactured by Abbott Diagnostics Division, Santa Clara, Ca || Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.
Worldwide Distribution -- United States (AL, AR, AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV), Canada, Germany, Puerto Rico, Singapore, and South Korea.
Description du dispositif
CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA. || Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory.