Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes. |
| Product | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte ester… |
| Quantity | 14340 units |
| Distribution | Worldwide Distribution and US Nationwide Distribution |
| Initiated | 2017-12-04 |
| Classified | 2018-05-17 |
| Terminated | 2023-05-30 |
| Recall number | Z-1893-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-1893-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79857/
Alerts for BECKMAN COULTER, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.