FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
- Recall number
- Z-0443-2019
- Recalling firm
- bioMerieux, Inc.
- Product
- bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
- Status
- Terminated
- Initiated
- 2018-10-08
- Posted
- not on file
- Terminated
- 2021-05-21
- Reason
- Some eluates become colored because of remaining hemoglobin in the eluate.
- Root cause
- 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 bioMrieux, Inc. representative. bioMrieux, 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 bioMrieux, 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
- 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
- Lot, serial or model codes
- Lot Z019EA1LB Exp. 28-MAY-2019.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28