FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: iChemVELOCITY Strips, Catalog 800-7212
- Recall number
- Z-1535-2020
- Recalling firm
- Beckman Coulter, Inc.
- Product
- iChemVELOCITY Strips, Catalog 800-7212
- Status
- Terminated
- Initiated
- 2020-02-17
- Posted
- not on file
- Terminated
- 2021-05-13
- Reason
- The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC.
- Quantity
- 10822 vials
- Distribution
- Distribution in US including Puerto Rico, Canada, and Taiwan
- Lot, serial or model codes
- Catalog 800-7212, UDI 10837461002628; Lot 7212269M
- 510(k) numbers
- ["K101852"]
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 3000203293
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28