CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report

Oxoid Legionella Latex Test, DR0800M, containing 50 tests recalled

Remel is recalling Oxoid Legionella Latex Test, DR0800M, containing 50 tests per, distributed in 11 states. The recall was initiated on 17 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014

Quantity recalled72/50-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-1473-2014
FDA event ID: 67777
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2014
FDA classified: 18 Apr 2014
Reported: 30 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

17 Mar 2014	Recall initiated by company
18 Apr 2014	Classified by FDA	+32 days
30 Apr 2014	Published in enforcement report	+12 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 contained within the product may return false negative results.

Product as listed by the FDA

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.

Where it was distributed

Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.

California Florida Illinois Massachusetts Maine New Jersey Pennsylvania Tennessee Texas Virginia Vermont

Questions about this recall

Is Oxoid Legionella Latex Test, DR0800M, containing 50 tests per recalled?

Yes. Remel recalled Oxoid Legionella Latex Test, DR0800M, containing 50 tests per on 17 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1473-2014.

Why was it recalled?

A reagent contained within the product may return false negative results.

Which lots are affected?

DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014

Where was it sold?

Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.

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

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