Device product
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.
Z-0466-2015
Product summary
- Firm
- Remel Inc
- Event
- Event 69566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59/50 test boxes
- Official record key
device-enforcement:Z-0466-2015
Official wording
Reason: A reagent within the test may return false negative results.
Code information: DR0800M box lot 1316151, 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.