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U.S. Department of Health and Human Services

Class 2 Device Recall NucliSENS Magnetic Extraction Reagents

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  Class 2 Device Recall NucliSENS Magnetic Extraction Reagents see related information
Date Initiated by Firm September 17, 2018
Create Date October 23, 2018
Recall Status1 Terminated 3 on May 18, 2020
Recall Number Z-0218-2019
Recall Event ID 81067
Product Classification General purpose reagent - Product Code PPM
Product NucliSENS¿ Magnetic Extraction Reagents
Code Information Reference # 200293, Lot # 17121501, Expiration date 11/28/2018
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
Manufacturer Reason
for Recall		 Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
FDA Determined
Cause 2		 Other
Action bioMerieux notified customers on about 09/17/2018 via "URGENT PRODUCT REMOVAL NOTICE". Instructions included the following. 1. Confirm this information has been distributed to, and reviewed by, all appropriate personnel within your organization. Retain a copy of this letter for your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product. 2. Please discontinue use and destroy any impacted product remaining in your local inventory and contact your local bioM¿rieux, Inc. representative for credit. 3. Among tests previously performed with these batches, we advise you to discuss patients results: identify any possible false results, retest impacted samples when possible, analyze the related risks and determine appropriate actions if relevant. 4. Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioM¿rieux, Inc. representative. Questions and concerns can be directed to Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656.
Quantity in Commerce 42 units
Distribution Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
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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