The Recall Desk
LowFDA (Devices)·Z-2081-2013·Announced 2013-09-04

Remel Recalls Oxoid Nitrofurantoin Antimicrobial Susceptibility Test Discs

Remel Inc is recalling specific lots of Oxoid Nitrofurantoin test discs because they may provide false susceptibility results.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the hazard is limited to potential false test results rather than direct physical injury.

Plain-English summary

Remel Inc is recalling 60 packs of Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B. The affected lots are 1194944 and 1198342. The product is packaged in cartridges of 50 discs, with 5 cartridges per pack, and is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.

The recall was initiated because the use of the affected lots may give a false indication of susceptibility to Nitrofurantoin. This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

The product was distributed in the United States, including the states of Alabama, Arkansas, California, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, New York, Oklahoma, Pennsylvania, Rhode Island, Texas, Virginia, and Washington. Users of the product should stop using the affected lots and contact Remel Inc for further instructions.

The recalled product

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 me
Manufacturer
Remel Inc
Affected units
60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lots 1194944 and 1198342

Distribution

Distributed in 17 states: