Reported Jan 25, 2017 · Terminated
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to…
BioMerieux SA
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile · N/A
Is this the product you have?
- NucliSENS magnetic extraction reagents, For in vitro diagnostic use
- Product UsageNucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens
- Lot codes and dates
- Reference number200293
- Lot number16072701
- Amount recalled
- 3723 units in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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