| Class 2 Device Recall iChem VELOCITY Automated Urine Chemistry System | |
Date Initiated by Firm | March 29, 2018 |
Date Posted | April 27, 2018 |
Recall Status1 |
Terminated 3 on June 27, 2019 |
Recall Number | Z-1894-2018 |
Recall Event ID |
79895 |
510(K)Number | K101852 |
Product Classification |
Automated urinalysis system - Product Code KQO
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Product | iChem 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
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For Additional Information Contact | Aruna 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 |
Action | The 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 Commerce | 6 devices |
Distribution | US Distribution to states of: AL, IA, GA, and FL. |
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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