FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
- Recall number
- Z-1937-2019
- Recalling firm
- Beckman Coulter Inc.
- Product
- iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
- Status
- Terminated
- Initiated
- 2018-10-18
- Posted
- not on file
- Terminated
- 2020-11-10
- Reason
- Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
- Root cause
- Component change control
- Action
- The recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue.
- Quantity
- 956,798/100 test strip vials
- Distribution
- Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.
- Lot, serial or model codes
- Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.
- 510(k) numbers
- ["K101852"]
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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