| Class 2 Device Recall iChem VELOCITY Automated Urine Chemistry System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KQO
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