Recall Z-0002-2008 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Beckman Coulter Inc
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
| Date | Oct 16, 2007 (initiated Feb 22, 2007) |
| Status | Terminated |
| Reason | Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. |
| Root cause | Labeling design |
| Action | A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be ven |
| Quantity | 9 in the U.S.; 1 in Canada |
| Distribution | Nationwide (MA, IN, IL, UT, RI, NJ), and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.