Z-0528-2014Class III

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5...

Name: Z-0528-2014 Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5...
Creator: Remel Inc
Published: 2012-11-21
License: https://open.fda.gov/license/

Remel Inc / initiated 2012-11-21 / Terminated / root cause: labeling and UDI

FDA source

Remel Inc began a recall of Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is... on 2012-11-21. FDA classified it as Class III and gives the reason as "Boxes labeled as CIP5 may contain cartridges of AMP5". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0528-2014
Classification: Class III
Status: Terminated
Initiated: 2012-11-21
Posted: 2013-12-17
Terminated: 2014-03-12
Recalling firm: Remel Inc
Product: Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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: Boxes labeled as CIP5 may contain cartridges of AMP5.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any product labeled AMP5. For questions regarding this recall call 913-895-4185.
Quantity in commerce: 60/5/50-disc cartridge boxes
Distribution: Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.
Product codes and lots: Lot number: 1220205, exp July 21, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0528-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0528-2014	Class III	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

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