Recall Z-1473-2014
Remel Inc · initiated March 17, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014
Reason for recall
A reagent contained within the product may return false negative results.
FDA-determined cause: Under Investigation by firm
Action taken
The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.
Details
- Recall number
- Z-1473-2014
- Initiated
- March 17, 2014
- Posted by FDA
- April 18, 2014
- Terminated
- December 11, 2014
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Quantity
- 72/50-test boxes
- Distribution
- Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
- Recalling firm
- Remel Inc, Lenexa, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1474-2014 Class II | Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box…A reagent contained within the product may return false negative results. | 03/17/2014Terminated |