Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a mi

FDA device recall Z-0028-2012 · posted 2011-10-07 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. Due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. This misalignment yields impaired reagen

Action taken

Beckman Coulter initiated an URGENT: PRODUCT CORRECTIVE ACTION (PCA) letter dated August 24, 2010, with attached PCA Response Form to all affected customers who purchased the Coulter PrepPlus 2. The letter provided the customers with an explanation of the problem identified and an action to be taken. The customers were instructed to not use the PrepPlus2 until their Beckman Coulter representative corrects the problem. A review of all results generated from samples prepared from the system should be conducted. Any unexpected dim fluorescence and/or decreased number stained cells should be evaluated for re-analysis, including preparing a new sample. Customers were also instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding this PCA, were instructed to call Beckman Coulter Customer service at (800) 526-7694. Outside of USA, customers were instructed to contact their local Beckman Coulter Representative.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

JQW

Quantity affected

391 units total (193 in US)

Distribution

Worldwide distribution.

Date initiated

2010-08-12

Date posted

2011-10-07

Date terminated

2012-04-04

Location

Brea, CA