FDA-Device2022-08-31Class II
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
bioMerieux, Inc.
Hazard
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
Sold states
Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.
Affected count
1,301 kits
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief