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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 System see related information
Date Initiated by Firm January 30, 2017
Date Posted March 01, 2017
Recall Status1 Terminated 3 on August 19, 2017
Recall Number Z-1384-2017
Recall Event ID 76374
510(K)Number K101852  
Product Classification Automated urinalysis system - Product Code KQO
Product iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061.
The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
Code Information Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934, V03933 V02027, V02022, V04322 V03288 V03314 V02330 V02326 V02329 V02642 V02323 V03571 V03428 V02909, V01251 V01115 V02081 V02248 V03575 V03854 V03403 V04387 V04388, V01406 V01556 V04328 V04390, V01557 V04141 V02103 V01214 V04227, V02438 v01838 V04284 V02535 V02534 V02449 V04312 V02538 V02635 V02530 V02450 V02634 V02485 V02436 V02614 V02463 V02652 V02502 V02536 V02464 V02423 V02435 V02432 V02649 V02459 V02537 V03883 V01689 V03409, V03413 V01753, V01754 V02243 V02985 V02242 V03976 V03851 V03925 V04369 V02026 V03848 V01404 V02430 V03565 V02234 V02373 V01829 V02446 V02703 V01429 V02949 V02899 V04309 V01318 V01546 V04257 V03566 V01548 V01547, V02753 V01541 V01542 V02369, V03922 V01555 V02181 V02070 V01762 V04357 V04350 V04349 V04356 V04291 V01720 V03834 V02335 V03798 V01911 V01998 V03567 V04258 V03238 V04329 V03327 V01776 V01712 V03271 V01966 V01824, 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V03263 V03015 V02947 V03041 V02425 V02362 V03056 V04021                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
FDA Determined
Cause 2
Device Design
Action Beckman Coulter/Iris sent an Urgent Medical Device Recall letter dated January 30, 2017 to all affected customers to inform them that Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to inadequate strip dosing. Customers were informed that Inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. Incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. The greatest impact could occur when proteinuria is not detected. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were 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 3175 units total (1697 units in US)
Distribution Worldwide Distribution - US (nationwide) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, 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, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic 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