FDAFDA · Food and drugs·Recall number Z-0465-2015
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.
Published December 3, 2014 · Recall initiated: October 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A reagent within the test may return false negative results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
- Lot
- DR0802M box lot 1301909, Exp. 30Sep2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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