Remel Recalls Oxoid Legionella Latex Test Due to False Negative Risk
Remel Inc is recalling specific lots of Oxoid Legionella Latex Test kits because a reagent may produce false negative results.
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 involves a risk-of-harm product (diagnostic test) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Remel Inc is recalling 72 boxes of the Oxoid Legionella Latex Test, DR0800M. The recall involves specific lot numbers for the test boxes and the included L. pneumophila Group 2-14 Latex Reagent, DR0802. The product is a medical diagnostic device used to detect Legionella bacteria.
The recall was initiated because a reagent contained within the product may return false negative results. This means the test could fail to detect the presence of Legionella, potentially leading to incorrect clinical decisions. The agency has classified this as a Class II recall.
The affected products were distributed to California, Florida, Illinois, Massachusetts, Maine, New Jersey, Pennsylvania, Tennessee, Texas, Virginia, and Vermont. There was no foreign, military, or government distribution. Users should stop using the affected lots and contact Remel Inc for further instructions.
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 Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
- Manufacturer
- Remel Inc
- Category
- Medical Device — Diagnostic Test
- 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 (6)
- DR0800M box lot numbers 1314413
- Exp. 30Jun2014
- and 1301907
- Exp. 31May2014
- DR0802 reagent bottle lot number 1265366
- exp. June 2014
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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