Recall Z-0465-2015— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2014-10-23, terminated 2015-01-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: A reagent within the test may return false negative results..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-23
- Terminated
- 2015-01-22
- Firm location
- Lenexa, KS, United States
Product description
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.
Reason for recall
A reagent within the test may return false negative results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.