Z-2081-2013Class III

Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of...

Name: Z-2081-2013 Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of...
Creator: Remel Inc
Published: 2013-03-25
License: https://open.fda.gov/license/

Remel Inc / initiated 2013-03-25 / Terminated

FDA source

Remel Inc began a recall of Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the... on 2013-03-25. FDA classified it as Class III and gives the reason as "Use of affected lots may give false indication of susceptibility to Nitrofurantoin". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2081-2013
Classification: Class III
Status: Terminated
Initiated: 2013-03-25
Posted: 2013-08-26
Terminated: 2014-06-03
Recalling firm: Remel Inc
Product: Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
FDA root cause: Unknown/Undetermined by firm
Action: ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).
Quantity in commerce: 60 packs
Distribution: US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
Product codes and lots: Lots 1194944 and 1198342

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2081-2013	Class III	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

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)