COULTER PrepPlus — Class II medical device recall Z-0002-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-10, distributed nationwide. The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience interm
| Recall number | Z-0002-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-01-20 |
| Classified | 2012-10-01 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2012-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, FR, JP, SE |
| Model numbers | 286600 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0002-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.