ThermoScientific Oxoid Antimicrobial Susceptibility Discs… recallZ-2142-2021 · Remel Inc · initiated Jun 18, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Out of Specification
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-2142-2021
- Status
- Terminated
- Initiated by the company
- Jun 18, 2021
- Recalling firm
- Remel Inc
- Quantity
- 327 units
- Product code
- JTN
- FDA submissions
- K982524
- 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.
Product description
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Code information (models, lots, serial numbers)
Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA CT0223BOxoid Limited · Susceptibility Test Discs, Antimicrobial1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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