FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
This recall has been terminated (originally issued October 16, 2007).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- February 22, 2007
- Posted
- October 16, 2007
- Terminated
- April 26, 2012
- Recall Number
- Z-0002-2008
- Quantity
- 9 in the U.S.; 1 in Canada
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
Distribution
Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.
Lot / Code Info
Part Number 624922. Software versions 1.1 & 1.2
Root Cause
Labeling design
Action Taken
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 vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.