Remel Recalls Oxoid Legionella Latex Test Due to False Negative Results
Remel Inc is recalling Oxoid Legionella Latex Test kits because a reagent may produce false negative results. The recall covers 59 boxes distributed nationwide.
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 2/5 (Moderate).
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. The hazard is a false negative result, which is a diagnostic error rather than a direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Remel Inc is recalling the Oxoid Legionella Latex Test, DR0800M, which contains 50 tests per box. The recall involves 59 boxes of the product. The specific component implicated is the Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The box lot number is 1316151, with an expiration date of September 30, 2014.
The recall was initiated because a reagent within the test may return false negative results. This means the test may fail to detect the presence of Legionella, potentially leading to incorrect clinical or environmental assessments.
The product was distributed nationwide, including in Arizona, California, the District of Columbia, Florida, Illinois, Maine, New Jersey, New York, Pennsylvania, Virginia, and Vermont. Users of the product should stop using the affected test kits and contact Remel Inc for further instructions or a replacement.
The recalled product
- Product
- Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
- Manufacturer
- Remel Inc
- Hazard
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 (2)
- DR0800M box lot 1316151
- Exp. 30Sep2014
Distribution
Part of a larger recall action
This product is one of 2 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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