iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry Syst
FDA device recall Z-1894-2018 · posted 2018-04-27 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KQO
- Quantity affected
- 6 devices
- Distribution
- US Distribution to states of: AL, IA, GA, and FL.
- Date initiated
- 2018-03-29
- Date posted
- 2018-04-27
- Date terminated
- 2019-06-27
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852) | Iris International Inc., A Division of Iris Iris I | 2011-03-23 |