FDA-Device2018-10-31Class II

NucliSENS¿ Magnetic Extraction Reagents

BioMerieux SA
Hazard

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Sold states
Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
Affected count
42 units
Manufactured in
Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, France
Products
NucliSENS¿ Magnetic Extraction Reagents

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0218-2019

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