Device 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.
Z-0002-2013
Product summary
- Event
- Event 63134
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units total (15 units in the US)
- Official record key
device-enforcement:Z-0002-2013
Official wording
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.
Code information: All Serial Numbers
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
Derived failure modes
-
Unknown
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.