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U.S. Department of Health and Human Services

Class 2 Device Recall iChem VELOCITY Automated Urine Chemistry System

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  Class 2 Device Recall iChem VELOCITY Automated Urine Chemistry System see related information
Date Initiated by Firm January 13, 2016
Create Date March 08, 2016
Recall Status1 Terminated 3 on August 29, 2016
Recall Number Z-1067-2016
Recall Event ID 73100
510(K)Number K101852  
Product Classification Automated urinalysis system - Product Code KQO
Product 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
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Gopal Mohanty
818-527-7379
Manufacturer Reason
for Recall		 Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.
FDA Determined
Cause 2		 Equipment maintenance
Action Iris sent an Urgent Medical Device Recall letter dated January 13, 2016 and an updated notification letter dated February 19, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions or concerns are instructed to contact their local support representative: ¿ Via our website, at http://www.beckmancoulter.com ¿ By phone, call 800 854-3633 in the United States and Canada.
Quantity in Commerce 2,661 units total (1,424 units in US)
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KQO and Original Applicant = IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
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