The Recall Desk

FDA (Devices) recall action 69566

Remel Inc recalled 2 products on 2014-12-03

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-12-03
Critical
0
Units
—

Why these products were recalled

A reagent within the test may return false negative results.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2014-12-03

    Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits

    Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predomi
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2014-12-03

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Results

    Remel Inc is recalling Oxoid Legionella Latex Test kits because a reagent may produce false negative results. The recall covers 59 boxes distributed nationwide.

    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.
    Category
    Distribution
    11 states