The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."

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 →

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