CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M recalled

Remel is recalling Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per, distributed nationwide in the US. The recall was initiated on 23 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDR0802M box lot 1301909, Exp. 30Sep2014

Quantity recalled2/50 test boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0465-2015
FDA event ID: 69566
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2014
FDA classified: 25 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

23 Oct 2014	Recall initiated by company
25 Nov 2014	Classified by FDA	+33 days
3 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A reagent within the test may return false negative results.

Product as listed by the FDA

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 predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.

Where it was distributed

Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.

Nationwide Arizona California District of Columbia Florida Illinois Maine New Jersey New York Pennsylvania Virginia Vermont

Questions about this recall

Why was it recalled?

A reagent within the test may return false negative results.

Which lots are affected?

DR0802M box lot 1301909, Exp. 30Sep2014

Where was it sold?

Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 69566

This product is part of a recall event; the main page for the event is Oxoid Legionella Latex Test, DR0800M, containing 50 tests recalled.

Reported	Class	Recall	Company	Reason	Where
3 Dec 2014	CLASS II	Oxoid Legionella Latex Test, DR0800M, containing 50 tests recalled	Remel	Other	Nationwide

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