The Recall Desk
ModerateFDA (Devices)·Z-0977-2017·Announced 2017-01-25

BioMerieux NucliSENS magnetic extraction reagents recalled for performance drift

BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, and the source text describes a performance drift without reporting specific injuries or illnesses, aligning with a moderate severity assessment for a diagnostic reagent.

Plain-English summary

BioMerieux SA is recalling NucliSENS magnetic extraction reagents, which are intended for the in vitro diagnostic extraction of total nucleic acids from biological specimens. The recall involves 3,723 units of the product, specifically reference number 200293 and lot number 16072701.

The recall was initiated because a drift in performance was observed for the BK test (BK virus, worst case application) for some silica batches of Magnetic Silica (MagSil). The source text notes that this is the same issue as in recall Z-2342-2016.

The product was distributed worldwide, including US Nationwide and through BioMerieux subsidiaries and distributors in numerous countries. Users of the affected reagents should stop using the product and contact BioMerieux SA for further instructions.

The recalled product

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.
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro Diagnostic Reagents
Hazard
Affected units
3,723

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Reference number: 200293
  • Lot number: 16072701.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by BioMerieux SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · BioMerieux SA

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Same hazard · performance drift

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