Z-0218-2019Class II

NucliSENS Magnetic Extraction Reagents

Name: Z-0218-2019 NucliSENS Magnetic Extraction Reagents
Creator: BioMerieux SA
Published: 2018-09-17
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-09-17 / Terminated

FDA source

BioMerieux SA began a recall of NucliSENS Magnetic Extraction Reagents on 2018-09-17. FDA classified it as Class II and gives the reason as "Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0218-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-17
Posted: 2018-10-23
Terminated: 2020-05-18
Recalling firm: bioMerieux, Inc.
Product: NucliSENS Magnetic Extraction Reagents
Product code: PPM General Purpose Reagent
Reason for recall: Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
FDA 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 in commerce: 42 units
Distribution: Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
Product codes and lots: Reference # 200293, Lot # 17121501, Expiration date 11/28/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0218-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0218-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)