Z-2142-2021Class II

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

Name: Z-2142-2021 ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Creator: Remel Inc
Published: 2021-06-18
License: https://open.fda.gov/license/

Remel Inc / initiated 2021-06-18 / Terminated

FDA source

Remel Inc began a recall of ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom on 2021-06-18. FDA classified it as Class II and gives the reason as "Out of Specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2142-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-18
Posted: 2021-07-26
Terminated: 2023-08-04
Recalling firm: Remel Inc
Product: ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Out of Specification
FDA root cause: Unknown/Undetermined by 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].
Quantity in commerce: 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.
Product codes and lots: Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2142-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2142-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-26

Product code JTN

K982524Class IIAmoxicillin/clavulanic Acid Antimicrobial Susceptibility Test DiscOxoid , Ltd. / cleared 1998-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)