FDA recall Z-1564-2022

bioMerieux, Inc. · Class II · device

Product

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

Reason for recall

There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-07-20
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2022