FDA-Device2014-12-03Class II

Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

Remel Inc
Hazard

A reagent within the test may return false negative results.

Sold states
Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
Affected count
59/50 test boxes
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0466-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief