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Class 3 Device Recall |
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Date Initiated by Firm |
June 06, 2003 |
Date Posted |
July 23, 2004 |
Recall Status1 |
Terminated 3 on August 30, 2004 |
Recall Number |
Z-1146-04 |
Recall Event ID |
28963 |
510(K)Number |
k993547
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Product Classification |
Method, Nephelometric, Immunoglobulins (G, A, M) - Product Code CFN
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Product |
IMMAGE IGALC Reagent
Part Number: 447460 |
Code Information |
Lots prior to M303259 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
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Manufacturer Reason for Recall |
Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
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FDA Determined Cause 2 |
Other |
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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510(K) Database |
510(K)s with Product Code = CFN and Original Applicant = BECKMAN COULTER, INC.
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