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U.S. Department of Health and Human Services

Class 2 Device Recall NucliSENS Lysis Buffer, REF 200292

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  Class 2 Device Recall NucliSENS Lysis Buffer, REF 200292 see related information
Date Initiated by Firm March 07, 2017
Date Posted March 19, 2017
Recall Status1 Terminated 3 on August 18, 2020
Recall Number Z-1713-2017
Recall Event ID 76675
Product Classification General purpose reagent - Product Code PPM
Product NucliSENS Lysis Buffer, REF 200292
NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Code Information Lot Number 16092902
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
Problem with colored eluates for whole blood extractions
FDA Determined
Cause 2
Under Investigation by firm
Action BioMerieux sent an Urgent Product Safety Correction Notice to all affected customers electronically on March 7, 2017. US customers will be sent a separate letter. The letter requested that they discard the product and notify all customers that use the product. The notification included a reply form to be returned. Customers with questions were instructed to contact their local bioMerieux Customer Service representative. For questions regarding this recall call 314-731-7301.
Quantity in Commerce 1025
Distribution Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.
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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