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Class 1 Device Recall VIDAS |
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Date Initiated by Firm |
August 06, 2003 |
Date Posted |
October 15, 2003 |
Recall Status1 |
Terminated 3 on May 17, 2005 |
Recall Number |
Z-1209-03 |
Recall Event ID |
26945 |
510(K)Number |
K915884
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Product Classification |
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) - Product Code LJC
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Product |
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101 |
Code Information |
Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004 |
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 |
Product's decrease in sensitivity may result in false negative results
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FDA Determined Cause 2 |
Other |
Action |
On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field. |
Quantity in Commerce |
2204 |
Distribution |
Nationwide
NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL,
WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI
International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA |
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 = LJC and Original Applicant = VITEK SYSTEMS, INC.
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