| Class 2 Device Recall NucliSENS Lysis Buffer, REF 200292 | |
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
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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
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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 |
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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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