Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

MagSIL (NucliSENS easyMAG Magnetic Silica) Recalled by BioMerieux SA Due to A drift of the performance with the BK...

Date: November 23, 2016
Company: BioMerieux SA
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BioMerieux SA directly.

Affected Products

MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.

Quantity: 3723 units in total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BioMerieux SA

BioMerieux SA has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report