ClearanceBrief
Recall Z-2142-2021 ยท JTN Susceptibility Test Discs, Antimicrobial

Remel Inc

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

DateJun 18, 2021
StatusTerminated
ReasonOut of Specification
Root causeUnknown/Undetermined by firm
ActionOn June 18, 2021 the firm sent letter to their consignees with the following info; To destroy any remaining inventory of the lot listed above and contact Technical Services regarding any necessary replacements. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
Quantity327 units
DistributionWorldwide 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 BERMUD
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K982524AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
Oxoid , Ltd., Sep 9, 1998