Device 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.
Z-0465-2015
Product summary
- Firm
- Remel Inc
- Event
- Event 69566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2/50 test boxes
- Official record key
device-enforcement:Z-0465-2015
Official wording
Reason: A reagent within the test may return false negative results.
Code information: DR0802M box lot 1301909, Exp. 30Sep2014
Distribution pattern: Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
Derived failure modes
-
Unknown
A reagent within the test may return false negative results.