Remel Recalls Oxoid Legionella Pneumo Groups 2-14 Test Kits
Remel Inc is recalling two boxes of Oxoid Legionella Pneumo Groups 2-14 test kits because a reagent may produce false negative results.
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 involves a risk-of-harm product where injury has not yet been reported, as the reagent may return false negative results.
Plain-English summary
Remel Inc is recalling two 50-test boxes of Oxoid Legionella Pneumo Groups 2-14, DR0802M. The product contains a variety of components, including the Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm listed on the label is Oxoid Ltd., Basingstoke, Hants, England.
The recall is being issued because a reagent contained within the product may return false negative results. The specific lot numbers involved are DR0802M box lot number 1265362 (Exp. 30Jun2014) and DR0802 reagent bottle lot number 1265366 (exp. June, 2014).
Distribution was made 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 product and contact Remel Inc for further instructions.
The recalled product
- Product
- Oxoid Legionella Pneumo Groups 2-14, DR0802M, 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
- 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 (5)
- DR0802M box lot number 1265362
- Exp. 30Jun2014
- 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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