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U.S. Department of Health and Human Services

Class 1 Device Recall NucliSENS magnetic extraction reagents

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  Class 1 Device Recall NucliSENS magnetic extraction reagents see related information
Date Initiated by Firm November 23, 2016
Date Posted January 13, 2017
Recall Status1 Terminated 3 on March 10, 2022
Recall Number Z-0977-2017
Recall Event ID 76026
Product Classification Reagent, general purpose - Product Code PPM
Product NucliSENS magnetic extraction reagents, For in vitro diagnostic use,

Product Usage:
NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
Code Information Reference number: 200293, Lot number: 16072701. 
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information Contact Ellen Weltmer
314-731-7301
Manufacturer Reason
for Recall		 A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016.
Quantity in Commerce 3723 units in total
Distribution Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
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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