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 | The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience intermittant reagent level sense failures where the instrument may not produce a warning that a reagent vial is low or out of reagent. |
| Product | COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. |
| Quantity | 36 units total (15 units in the US) |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden. |
| Initiated | 2012-01-20 |
| Classified | 2012-10-01 |
| Terminated | 2012-10-02 |
| Recall number | Z-0002-2013 |
| 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-0002-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63134/
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.