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U.S. Department of Health and Human Services

Class 2 Device Recall NUCLISENS Lysis Buffer

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  Class 2 Device Recall NUCLISENS Lysis Buffer see related information
Date Initiated by Firm October 08, 2018
Create Date November 09, 2018
Recall Status1 Terminated 3 on May 21, 2021
Recall Number Z-0443-2019
Recall Event ID 81323
Product Classification General purpose reagent - Product Code PPM
Product bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Code Information Lot Z019EA1LB Exp. 28-MAY-2019.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Customer Service representative
800-682-2666
Manufacturer Reason
for Recall		 Some eluates become colored because of remaining hemoglobin in the eluate.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Required Actions We request you to take the following actions at this time: -Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Stop using the NUCLISENS Lysis Buffer, Ref. 280134, Lot: Z019EA1LB, exp. 28-MAY-2019, and destroy any stock of this lot Z019EA1LB you might have in your laboratory. -Discuss any concern you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. -Contact your local bioMerieux, Inc. Customer Service representative if you have observed the issue and if you have a doubt regarding your results. -Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioM¿rieux, Inc. representative. bioM¿rieux, Inc. is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused your business. If you require additional assistance or have any questions, please contact your local bioM¿rieux, Inc. Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656. For non-urgent inquiries, please contact the Clinical Technical Support Center by email at CustomerService-ImmunoMolecular@biomerieux.com. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM  7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.
Quantity in Commerce 268
Distribution CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh
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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