Z-1246-2014Class II

Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label...

Name: Z-1246-2014 Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label...
Creator: Remel Inc
Published: 2014-02-18
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-02-18 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England... on 2014-02-18. FDA classified it as Class II and gives the reason as "Some of the discs may not be impregnated with the antibiotic". 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-1246-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-03-20
Terminated: 2014-06-25
Recalling firm: Remel Inc
Product: Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Some of the discs may not be impregnated with the antibiotic.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed, customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) and 913-888-0939 (International). For questions regarding this recal lcall 913-895-4185.
Quantity in commerce: 40/5/50-disc cartridge packages
Distribution: Nationwide Distribution
Product codes and lots: Lot 1174497, exp. 2015/04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1246-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1246-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-20

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)