UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc.

FDA device recall Z-1097-2008 · posted 2008-05-24 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.

Action taken

GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

71 in the US

Distribution

Worldwide Distribution - USA including Canada.

Date initiated

2007-04-05

Date posted

2008-05-24

Date terminated

2013-01-15

Location

Brea, CA

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