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U.S. Department of Health and Human Services

Class 2 Device Recall iChemVELOCITY Automated Urine Chemistry System

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 Class 2 Device Recall iChemVELOCITY Automated Urine Chemistry Systemsee related information
Date Initiated by FirmJuly 15, 2015
Date PostedAugust 21, 2015
Recall Status1 Terminated 3 on May 26, 2016
Recall NumberZ-2441-2015
Recall Event ID 71780
510(K)NumberK101852 
Product Classification Automated urinalysis system - Product Code KQO
ProductiChemVELOCITY 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. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Iris Diagnostics
9172 Eton Ave
Chatsworth CA 91311-5805
For Additional Information ContactArnd Kaldowski
714-993-5321
Manufacturer Reason
for Recall		Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn Urgent Medical Device Recall letter dated 7/15/15 was sent to all customers who purchased the iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips REF 800-7212 and 800-7212-001. As a result of internal investigations following customer complaints, Iris International has determined that the iChemVELOCITY systems do not maintain the on-board strip stability claim of 5 days at 18-28C at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions or concerns regarding the recall notice, are instructed to contact Beckman Coulter Customer Support at http://www.beckmancoulter.com or call (800) 526-7694 in US and Canada.
Quantity in Commerce2,448 units
DistributionWorldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KQO
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