The Recall Desk

FDA (Devices) recall action 76026

BioMerieux SA recalled 2 products on 2017-01-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-01-25
Critical
0
Units
7,446

Why these products were 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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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.

    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.
    Category
    Distribution
    1 state
  • LowFDA (Devices)··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.

    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.
    Category
    Distribution
    1 state