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
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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
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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 |
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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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