Z-2342-2016Class I

NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be...

Name: Z-2342-2016 NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be...
Creator: BioMerieux SA
Published: 2016-07-08
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-07-08 / Terminated

FDA source

BioMerieux SA began a recall of NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which... on 2016-07-08. FDA classified it as Class I and gives the reason as "Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2342-2016
Classification: Class I
Status: Terminated
Initiated: 2016-07-08
Posted: 2016-08-09
Terminated: 2022-03-10
Recalling firm: bioMerieux, Inc.
Product: NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.
Product code: LDT
Reason for recall: Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
FDA root cause: Under Investigation by firm
Action: Consignees were notified of the recall by letter on July 18, 2016. The letter informed them of what actions need to be taken if they experience problems. The letter included a reply form to be returned. Subsidiaries and distributors were notified electronically on 7/8/2016.
Quantity in commerce: 7,845 units
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Colombia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe
Product codes and lots: Lots - Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2342-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2342-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-09

Product code LDT

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)