Z-0443-2016Class II

Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5...

Name: Z-0443-2016 Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5...
Creator: Remel Inc
Published: 2015-11-06
License: https://open.fda.gov/license/

Remel Inc / initiated 2015-11-06 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the... on 2015-11-06. FDA classified it as Class II and gives the reason as "Antibiotic concentration may be insufficient which may result in incorrect test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0443-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-06
Posted: 2015-12-17
Terminated: 2017-02-13
Recalling firm: Remel Inc
Product: Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Antibiotic concentration may be insufficient which may result in incorrect test results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated November 6, 2015, to all affected customers via first class mail. The recall notice identified the problem with the device and asked customers to inspect their stocks for the affected lots. The notice instructed customers to destroy any remaining inventory from the affected lots, contact the recalling firm for replacement, and complete the accompanying Acknowledgement form. Customers with questions were instructed to contact the Technical Services Departmentn at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-895-4077.
Quantity in commerce: 58/5/50 discs/catridges/packs
Distribution: Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.
Product codes and lots: Lot 1686823, expiry 30 June 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0443-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0443-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-17

Product code JTN

K860153Class IIOxoid Antimicrobial Susceptibility DiscsOxoid U.S.A., Inc. / cleared 1986-03-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)