Oxoid Legionella Latex Test

Model: DR0800M, Affected: Lot: 1316151

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

Immunology and Microbiology Devices

1

No

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

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.

DR0802M box lot 1301909, Exp. 30Sep2014

Immunology and Microbiology Devices

1

No

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

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.

Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in vitro diagnostic medical device (IVD))Oxoid Legionella Latex Test (DR0800M)Lot Numbers: 1314413 and 1301907Oxoid Legionella Pneumophila Serogroup 2-14 Test Reagent (DR0802M)Lot Number: 1265362