Recall Z-2142-2021
Remel Inc · initiated June 18, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Codes / lots: Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533
Reason for recall
Out of Specification
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-2142-2021
- Initiated
- June 18, 2021
- Terminated
- August 4, 2023
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Quantity
- 327 units
- 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.
- Recalling firm
- Remel Inc, Lenexa, KS