Reported Dec 3, 2014 · Terminated

Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of…

Remel Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519

Is this the product you have?

5 of 5 products

Products covered by this recall
#Product as published
1Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L.
2pneumophila Group 2-14 Latex Reagent
3Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella
4pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L.
5pneumophila, Legionella strains.
Lot codes and dates
    • DR0802M box lot 1301909
    • Exp. 30Sep2014
Amount recalled
2/50 test boxes

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

A reagent within the test may return false negative results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 22, 2015 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.