Recall Z-0466-2015— Remel Inc

Name: FDA recall Z-0466-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-23

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2014-10-23, terminated 2015-01-22. 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 Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.. Reason: A reagent within the test may return false negative results..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Terminated: 2015-01-22
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 Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.

Reason for recall

A reagent within the test may return false negative results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.