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 | There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. |
| Product | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. |
| Quantity | 180 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe. |
| Initiated | 2021-07-15 |
| Classified | 2021-08-23 |
| Terminated | 2024-06-04 |
| Recall number | Z-2332-2021 |
| 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-2332-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88339/
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