The Recall Desk
ModerateFDA (Devices)·Z-1232-2015·Announced 2015-03-11

Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negatives

Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A because it may fail to recover Legionella pneumophila, leading to false negative test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries. The hazard is a diagnostic error (false negatives) rather than a direct physical injury, fitting the criteria for a moderate severity score.

Plain-English summary

Remel Inc is recalling 24 packs of Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials. The product is identified by Lot No. 1545171. The label identifies the responsible firm as Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.

The recall was initiated because the use of this product may not provide adequate recovery of Legionella pneumophila. This deficiency could result in false negative identification of the bacteria, potentially compromising the accuracy of laboratory testing.

The affected product was distributed in the United States to the states of Michigan, North Dakota, South Carolina, Tennessee, and Texas. Users of this product should stop using it and contact Remel Inc for further instructions.

The recalled product

Product
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
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 (1)

  • Lot No. 1545171

Distribution

Distributed in 5 states: