Z-0734-2014Class II

Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs...

Name: Z-0734-2014 Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs...
Creator: Remel Inc
Published: 2013-11-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2013-11-21 / Terminated

FDA source

Remel Inc began a recall of Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per... on 2013-11-21. FDA classified it as Class II and gives the reason as "Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0734-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2014-01-14
Terminated: 2014-12-11
Recalling firm: Remel Inc
Product: Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. 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: Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
FDA root cause: Unknown/Undetermined by firm
Action: Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it. If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in commerce: 45/5/50 - discs/cartridges/packs
Distribution: Nationwide Distribution including the states of AL, AZ, CA, CO, FL, HI, IA, IL, KY, LA, MD, MI, MN, MO, MS, NC, NY, OH, SC, TN, TX, VA, WI, and WV
Product codes and lots: Lot number: 1223566 EXP: 8/31/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0734-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0734-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

Product code JTN

K983718Class IIMeropenem Antimicrobial Susceptibility Test DiscOxoid , Ltd. / cleared 1998-12-11

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)