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 Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
Z-1473-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 67777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72/50-test boxes
- Official record key
device-enforcement:Z-1473-2014
Official wording
Reason: A reagent contained within the product may return false negative results.
Code information: DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014
Distribution pattern: Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
A reagent contained within the product may return false negative results.