FDA recall Z-2142-2021

Remel Inc · Class II · device

Product

ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom

Reason for recall

Out of Specification

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. The countries of BERMUDA.

Key facts

Status
Terminated
Initiation date
2021-06-18
Report date
2021-08-04
Termination date
2023-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2142-2021