Recall Z-1473-2014— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2014-03-17, terminated 2014-12-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A reagent contained within the product may return false negative results..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-17
- Terminated
- 2014-12-11
- Firm location
- Lenexa, KS, United States
Product description
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.
Reason for recall
A reagent contained within the product may return false negative results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.