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U.S. Department of Health and Human Services

Class 2 Device Recall FP1000 Cell Preparation System

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 Class 2 Recall
FP1000 Cell Preparation System
see related information
Date Posted October 16, 2007
Recall Status1 Open
Recall Number Z-0002-2008
Recall Event ID 38369
Product Classification Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use - Product Code LXG
Product FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Code Information Part Number 624922. Software versions 1.1 & 1.2
Recalling Firm/
Manufacturer
Beckman Coulter Inc
200 S Kraemer Blvd
Brea, California 92822-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall
Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
FDA Determined
Cause 2
DESIGN: 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 vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.
Quantity in Commerce 9 in the U.S.; 1 in Canada
Distribution Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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