The Recall Desk
HighFDA (Devices)·Z-1112-2014·Announced 2014-03-05

Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to Contamination

Remel Inc is recalling specific lots of Oxoid Legionella BCYE Growth Supplement because the product may contain high levels of microbial contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves high levels of microbial contamination in a medical device used for clinical isolation, which fits the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).

Plain-English summary

Remel Inc is recalling specific lots of Oxoid Legionella BCYE Growth Supplement, SR0110C. The product is a lyophilized supplement used for the isolation of Legionella species from clinical and environmental samples. The recall is being conducted because the product may contain high levels of microbial contamination.

The affected product is packaged in boxes of 10 vials. The specific lots subject to the recall are Lot 1380784 (Expiration: 31Aug2015) and Lot 1367905 (Expiration: 31Jul2015). The total quantity recalled is 44 boxes.

The product was distributed in the United States, including Puerto Rico, and in the states of Florida, Illinois, Massachusetts, Maine, Michigan, and Pennsylvania. Users should stop using the affected product and contact Remel Inc for further instructions.

The recalled product

Product
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samp
Manufacturer
Remel Inc

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 (4)

  • Lot 1380784
  • Exp. 31Aug2015
  • and Lot 1367905
  • Exp. 31Jul2015

Distribution

Distributed in 7 states: