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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 Systemsee related information
Date Initiated by FirmMarch 29, 2018
Date PostedApril 27, 2018
Recall Status1 Terminated 3 on June 27, 2019
Recall NumberZ-1894-2018
Recall Event ID 79895
510(K)NumberK101852 
Product Classification Automated urinalysis system - Product Code KQO
ProductiChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
Code Information Catalog 700-7176-001 - Serial numbers V04494 and CV04015;   Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactAruna Badiga, Ph. D.
305-380-4189
Manufacturer Reason
for Recall
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
FDA Determined
Cause 2
Process control
ActionThe recalling firm, Beckman Coulter/IRIS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated dated 3/26/2018 via email on 3/29/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Follow the on-board strip stability claims per Table 1 to determine the frequency at which the strips need to be changed. -Whenever the Strip Provider Module is accessed (i.e., opened or when loading strips), remove and discard the remaining on-board strips and desiccant before replenishing. -It is suggested that for the tests performed since the installation of the iChemVELOCITY/SPM housing assembly, consult with your Laboratory Director to determine whether a retrospective review of results is clinically warranted. -Complete and return the CUSTOMER RESPONSE FORM within 10 days by email to: Regulatory.Notifications@beckman.com, Please include FA-33476 iChemVELOCITY Automated Urine Chemistry System in e-mail subject field or by mail to:Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06 11800 S.W. 147th Avenue, P O BOX 169015, Miami, FL 33116-9015. -Beckman Coulter will contact you by phone to schedule a site visit for replacing the SPM on your instrument. -Beckman Coulter will be implementing process improvements to prevent this issue from recurring. If you have any questions regarding this notice, please contact: - From our website: http://www.beckmancoulter.com - By phone: call 800-854-3633 in the United States and Canada. -Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in Commerce6 devices
DistributionUS Distribution to states of: AL, IA, GA, and FL.
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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