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 | Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. |
| Product | Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. |
| Quantity | 57,962 units (50,452 units in the US) |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica. |
| Initiated | 2012-12-28 |
| Classified | 2013-03-15 |
| Terminated | 2013-10-17 |
| Recall number | Z-0958-2013 |
| 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-0958-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64162/
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