The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0976-2017·Announced 2017-01-25

BioMerieux Recalls MagSIL Magnetic Silica Reagents Due to Performance Drift

BioMerieux SA is recalling 3,723 units of MagSIL (NucliSENS easyMAG Magnetic Silica) worldwide due to observed performance drift in BK virus testing.

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 3,723 units of MagSIL (NucliSENS easyMAG Magnetic Silica) distributed worldwide. The product is an in vitro diagnostic medical device intended for the automated isolation, purification, and concentration of total nucleic acids (RNA/DNA) from biological specimens.

The recall was initiated because a drift in performance was observed for the BK virus test, which is considered the worst-case application for this product. The source text notes that this is the same issue addressed in a previous recall, Z-2342-2016. The affected units are identified by reference number 280133 and specific lot numbers: Z017KA1MS, Z017KB1MS, Z017LE1MS, Z017MA1MS, Z017NA1MS, Z017NB1MS, Z017NC1MS, and Z017ND1MS.

The affected products were distributed to BioMerieux subsidiaries and distributors in numerous countries, including the United States, Canada, and various nations in Europe, Asia, South America, and Africa. No specific instructions for consumers or healthcare providers are provided in the source text.

The recalled product

Product
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.
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro Diagnostic
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 (8)

  • Reference number: 280133
  • Lot numbers: Z017KA1MS
  • Z017KB1MS
  • Z017LE1MS
  • Z017MA1MS
  • Z017NA1MS
  • Z017NB1MS
  • Z017NC1MS and Z017ND1MS.

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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