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Class 2 Device Recall VIDAS CMV IgG |
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Date Initiated by Firm |
June 09, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on January 12, 2005 |
Recall Number |
Z-1047-04 |
Recall Event ID |
29330 |
510(K)Number |
K920661
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Product Classification |
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
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Product |
VIDAS¿ CMV IgG Assay |
Code Information |
Catalog #30 204, Lot #782887501 |
Recalling Firm/ Manufacturer |
bioMerieux 100 Rodolphe Street Building 1300 Durham NC 27712
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For Additional Information Contact |
Anita M. McClernon, MS, RAC 919-620-2288
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Manufacturer Reason for Recall |
The product may give false positive results.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on June 9, 2004. |
Quantity in Commerce |
148 units |
Distribution |
AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA. |
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 = LFZ and Original Applicant = VITEK SYSTEMS, INC.
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