Recall of Device Recall Beckman Coulter FP1000 Cell Preparation System

Recall

35778

Class 2

Z-1466-06

2006-06-26

2006-08-31

Terminated

United States

2012-04-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46858

During the cleaning cycle performed during the shutdown procedure of the beckman coulter fp1000 cell preparation system, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.

A Product Corrective Action letter was sent on June 26, 2006 informing users that during the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results. To reduce the risk of incorrect results from dripping fluid, users were advised to remove all patient samples, reagents, controls, and calibrators before initiating the shutdown cycle of the Beckman Coulter FP1000. Software will be modified in the next version to prevent the possibility of dripping bleach during the shutdown cycle. The Product Corrective Action letter is to be maintained as part of the customer''s laboratory Quality System documentation. The enclosed Response Form is to be completed and returned within 10 days to the recalling firm. Customers are also advised to contact the firm or their local Beckman Coulter Representative if there are questions.