ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM

IVD Other

Model: 800-3042, 800-3043, 800-3044, 800-3075, 800-3076, 800-3564, 800-7100, 800-7101, 800-7102, 800-7103, 800-7106, 800-7157, 800-7162, 800-7163, 800-7166, Affected: Manufactured between Apr-2011 and Jun-2015

Model: 800-7204, 800-7204FJR, Affected: all lots

ivd

all serial numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Affected geographies: Argentina, Australia, Austria, Bangladesh, Bermuda, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico , Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic, United States (including Puerto Rico), and Venezuela

iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 || iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001