Recalls / —

—#188130

Product

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

FDA product code

JTN — Susceptibility Test Discs, Antimicrobial

Device class

Class 2

Medical specialty

Microbiology

510(k) numbers

K982524

Affected lot / code info

Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533

Why it was recalled

Out of Specification

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

On 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.

Recalling firm

Firm

Remel Inc

Address

12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2021-06-18

Terminated

2023-08-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #188130. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.