ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
FDA Recall Z-2142-2021 · Posted None
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTN
Date Initiated2021-06-18
Date Terminated2023-08-04
Product Quantity327 units
Reason for Recall
Out of Specification
Firm Action
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].
Root Cause
Unknown/Undetermined by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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