Z-0808-2013Class II

Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5...

Name: Z-0808-2013 Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5...
Creator: Remel Inc
Published: 2012-08-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2012-08-21 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on... on 2012-08-21. FDA classified it as Class II and gives the reason as "The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of 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-0808-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-21
Posted: 2013-02-12
Terminated: 2013-06-04
Recalling firm: Remel Inc
Product: Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.
Quantity in commerce: 23 units
Distribution: US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,
Product codes and lots: Lot 1186069

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0808-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0808-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-12

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