Recall Z-0002-2013 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Beckman Coulter Inc.
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.
| Date | Oct 1, 2012 (initiated Jan 20, 2012) |
| 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. |
| Root cause | Device Design |
| Action | Beckman Coulter sent an Urgent Product Correction letter dated January 20, 2012 to all their customers who purchased the affected product. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to complete and return the Response Form with in 10 days. Customers with questions regarding the PCA letter were instructed to contact Beckman Coulter Service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter Representative. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.