Recall Z-1466-06 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Beckman Coulter Inc
FP1000 Cell Preparation System Part Number 624922
| Date | Aug 31, 2006 (initiated Jun 26, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 |
| Quantity | 11 units distributed |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.