FDA Medical Device Recalls (openFDA)
BioMerieux SA: NucliSENS Magnetic Extraction Reagents
- Recall number
- Z-0218-2019
- Recalling firm
- BioMerieux SA
- Product
- NucliSENS Magnetic Extraction Reagents
- Status
- Terminated
- Initiated
- 2018-09-17
- Posted
- not on file
- Terminated
- 2020-05-18
- Reason
- Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
- Root cause
- 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 bioMrieux, 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 bioMrieux, 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
- 42 units
- Distribution
- Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
- Lot, serial or model codes
- Reference # 200293, Lot # 17121501, Expiration date 11/28/2018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
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