Remel Inc: Medical Device Recall in 2015 - (Recall #: Z-0443-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. 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 Classification:

Class II

Date Initiated: November 6, 2015

Date Posted: December 23, 2015

Recall Number: Z-0443-2016

Event ID: 72525

Reason for Recall:

Antibiotic concentration may be insufficient which may result in incorrect test results.

Status: Terminated

Product Quantity: 58/5/50 discs/catridges/packs

Code Information:

Lot 1686823, expiry 30 June 2018

Distribution Pattern:

Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated