FDA-Device2012-10-10Class II
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.
Beckman Coulter Inc.
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Australia, Botswana, Canada, France, Germany, Japan, Malawi and Sweden.
Affected count
36 units total (15 units in the US)
Manufactured in
250 S Kraemer Blvd, M/S A2.SW.01, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2013Don't want to check this manually?
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