FP1000 Cell Preparation System Part Number 624922
This recall has been terminated (originally issued August 31, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- June 26, 2006
- Posted
- August 31, 2006
- Terminated
- April 26, 2012
- Recall Number
- Z-1466-06
- Quantity
- 11 units distributed
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and Canada
Lot / Code Info
Software Version 1.0
Root Cause
Other
Action Taken
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.