—#163822

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.

FDA product code: KQO — Automated Urinalysis System
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K101852
Affected lot / code info: Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.

Why it was recalled

The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: US Distribution to states of: AL, IA, GA, and FL.

Timeline

Recall initiated: 2018-03-29
Posted by FDA: 2018-04-27
Terminated: 2019-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.