The Recall Desk

FDA (Devices) recall action 67777

Remel Inc recalled 2 products on 2014-04-30

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
2014-04-30
Critical
0
Units
—

Why these products were recalled

A reagent contained within the product may return false negative results.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-04-30

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Risk

    Remel Inc is recalling specific lots of Oxoid Legionella Latex Test kits because a reagent may produce false negative results.

    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.
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2014-04-30

    Remel Recalls Oxoid Legionella Pneumo Groups 2-14 Test Kits

    Remel Inc is recalling two boxes of Oxoid Legionella Pneumo Groups 2-14 test kits because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14, 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, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Distribution
    11 states