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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 Device Recall FP1000 Cell Preparation System see related information
Date Initiated by Firm February 22, 2007
Date Posted October 16, 2007
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-0002-2008
Recall Event ID 38369
Product Classification flow cytometer cell preparation - 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 CA 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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