Z-0977-2017Class I

NucliSENS magnetic extraction reagents, For in vitro diagnostic use

Name: Z-0977-2017 NucliSENS magnetic extraction reagents, For in vitro diagnostic use
Creator: BioMerieux SA
Published: 2016-11-23
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-11-23 / Terminated / root cause: manufacturing process

FDA source

BioMerieux SA began a recall of NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG is intended to be used for the extraction of total... on 2016-11-23. FDA classified it as Class I and gives the reason as "A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0977-2017
Classification: Class I
Status: Terminated
Initiated: 2016-11-23
Posted: 2017-01-13
Terminated: 2022-03-10
Recalling firm: bioMerieux, Inc.
Product: NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG is intended to be used for the extraction of total nucleic acids from biological specimens.
Product code: PPM General Purpose Reagent
Reason for recall: A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016.
Quantity in commerce: 3723 units in total
Distribution: Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
Product codes and lots: Reference number: 200293, Lot number: 16072701.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0977-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0976-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13
Z-0977-2017	Class I	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13

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