Remel Legionella Growth Supplement Recalled for Potential False Negative Results
Remel Inc is recalling Legionella BCYE Growth Supplement because it may fail to recover Legionella pneumophila, leading to false negative identification.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a diagnostic failure (false negatives) for a high-risk pathogen (Legionella), which fits the criteria for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials (10 per package). The product is a growth supplement used for the isolation of Legionella. The recall involves 16 packages of 10 vials each, with lot number 1451506 and an expiration date of February 26, 2016.
The recall was initiated because the product may not provide adequate recovery of Legionella pneumophila when used as directed. This defect may result in false negative identification of the bacteria. The affected units were distributed in the states of North Dakota, Vermont, and Texas.
Users of this product should stop using it and contact Remel Inc for further instructions. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
- 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 Number: 1451506 Expiration: 26Feb2016
Distribution
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