Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0465-2015·Announced 2014-12-03

Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits

Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test 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 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, and the hazard is a false negative result which is a diagnostic error rather than a direct physical injury or contamination, fitting the Moderate criteria for low-risk issues or voluntary precautionary recalls.

Plain-English summary

Remel Inc is recalling two boxes of the Oxoid Legionella Pneumo Groups 2-14 Latex Test, product code DR0802M. The recalled items are identified by box lot 1301909 and an expiration date of September 30, 2014. Each box contains 50 tests, including the Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912.

The recall was initiated because a reagent within the test may return false negative results. This product is a latex agglutination test used to identify predominant Legionella species from patients with suspected Legionellosis or from environmental sources. The test is designed to allow separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14, as well as the detection of other pathogenic non L. pneumophila Legionella strains.

The affected products were distributed nationwide, including in Arizona, California, the District of Columbia, Florida, Illinois, Maine, New Jersey, New York, Pennsylvania, Virginia, and Vermont. Users of these specific test kits should stop using them and contact Remel Inc for further instructions.

The recalled product

Product: Oxoid Legionella Pneumo Groups 2-14 Latex Test, 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, Lot 1301912. The product is a latex agglutination test for the identification of…
Manufacturer: Remel Inc
Category: Medical Device — Laboratory Diagnostic Test
Hazard: false-negative-result

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)

DR0802M box lot 1301909
Exp. 30Sep2014

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Remel Inc

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